FDA UDI
In Commercial Distribution
🇺🇸 United States
Marshall TOTAL KNEE PACK-LF
DI: 00817395022698
·
Model: MM330
·
PACKROOM LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Marshall TOTAL KNEE PACK-LF
- Primary DI
- 00817395022698
- Version / Model
- MM330
- Company Name
- PACKROOM LLC
- Labeler DUNS
- 015179820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-10
- Public Version
- 1
- Public Version Date
- 2021-11-18
- Public Version Status
- New
- Public Device Record Key
- c4c68b25-62e8-48c4-95a3-d51afe88f60c
Device Description
Marshall TOTAL KNEE PACK-LF
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61781 | Joint prosthesis implantation kit, single-use | A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817395022698 | GS1 |