FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867192676
·
Model: AR-3210-0009
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867192676
- Version / Model
- AR-3210-0009
- Catalog Number
- AR-3210-0009
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-30
- Public Version
- 4
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 7ae14649-d01c-414c-b384-fdc5c4e2e9a3
Device Description
Coupler, 90 Degree, C-MT
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEM | ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36292 | Endoscope camera adaptor | An optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888867192676 | GS1 |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]