Contract manufacturerPACKROOM LLC (Mc Donough, GA)GeorgiaGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalObstetrics and gynecologyCardiovascularClass IIClass I
PACKROOM LLC
Contract manufacturer · Mc Donough, GA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3008513424 (openFDA record; or search FDA's registration database)
- FEI number
- 3008513424
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Pack Room LLC (FDA owner/operator no. 10030702)
- Registered address
- 1281 Highway 155 South, Mc Donough, GA 30253
- Contract listings
- 8 device listings, 8 product codes, first listed Jul 15, 2010
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FDE | Laparoscopy Kit | Class II | Gastroenterology and urology | Contract manufacturing | Jun 21, 2022 |
| LRP | Tray, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 27, 2012 |
| LRS | I.V. Start Kit | Class II | General hospital | Contract manufacturing | Jan 31, 2019 |
| MLS | Labor And Delivery Kit | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 15, 2010 |
| OEQ | Angiography/Angioplasty Kit | Class II | Cardiovascular | Contract manufacturing | Jul 15, 2010 |
| OES | Cardiac Catheterization Kit | Class II | Cardiovascular | Contract manufacturing | Jul 15, 2010 |
| OHM | Cesarean Section Tray | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 15, 2010 |
| PWM | Admission Kit (Patient Utensil) | Class I | General hospital | Contract manufacturing | Jan 31, 2019 |