FDA UDI
In Commercial Distribution
🇺🇸 United States
BEE PLIF
DI: 04251631416005
·
Model: Shaver 9 x 24 mm
·
NGMedical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BEE PLIF
- Primary DI
- 04251631416005
- Version / Model
- Shaver 9 x 24 mm
- Catalog Number
- I331
- Company Name
- NGMedical GmbH
- Labeler DUNS
- 342615118
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-07
- Public Version
- 1
- Public Version Date
- 2023-11-15
- Public Version Status
- New
- Public Device Record Key
- f3b91c1a-b54f-4e5b-8186-a8240a80e7f9
Device Description
All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251631416005 | GS1 |