FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867424067
·
Model: AR-10920F-1
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867424067
- Version / Model
- AR-10920F-1
- Catalog Number
- AR-10920F-1
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-06
- Public Version
- 3
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 3a2211a2-f8bb-48b3-9030-e0ba199fc18d
Device Description
Nano Suction Biter 70mm Flat Tip 1 PK
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 32856 | Orthopaedic implant impactor, reusable | A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888867424067 | GS1 |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]