FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867043626
·
Model: AR-8400RBE
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867043626
- Version / Model
- AR-8400RBE
- Catalog Number
- AR-8400RBE
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-03
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- f182704b-7f02-45db-8950-f0ebc934db3b
Device Description
BURR, ROUND, 8 FLUTE 4.0MM X 13CM
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36224 | Arthroscopic shaver system, electrically-powered | A dedicated assembly of electrically-powered devices designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It typically consists of a power supply/control unit with operational display and dedicated software, intended to provide optimal parameters for the procedure, and a rotatory handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotatory instruments. An irrigation system may be included. Common procedures include cartilage debridement (e.g., meniscus repair or meniscectomy) and removal of the inflamed inner lining of the joint (synovectomy). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10888867043623 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00888867043626 | GS1 |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]