FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthrex®
DI: 00888867041257
·
Model: AR-7199
·
ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Arthrex®
- Primary DI
- 00888867041257
- Version / Model
- AR-7199
- Catalog Number
- AR-7199
- Company Name
- ARTHREX, INC.
- Labeler DUNS
- 131747628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 5
- Public Version Date
- 2021-04-26
- Public Version Status
- Update
- Public Device Record Key
- 89512a9f-3d7d-4c98-8bda-cd38f3e2e687
Device Description
FINGERSHIELDS
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
- No
- 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 |
|---|---|---|---|---|
| LZB | Finger cot | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41138 | Surgical finger guard | A cap intended to be placed over the gloved, non-dominant index finger of a surgical staff hand to provide protection from blood contamination and to reduce accidental needle-sticks and scalpel cuts during a surgical procedure. It is a tough, thimble-like shell with a repellent surface designed with specific features (e.g., notches, protrusions) to help guide a needle tip insertion while protecting the fingertip of the wearer. It is typically used for blunt tissue dissection, to prevent blood vessel punctures, and for interventions such as bladder neck suspension, episiotomy repair and colporrhaphy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888867041257 | GS1 | ||||
| Secondary | M150AR71991 | HIBCC | ||||
| Package | 10888867041254 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)934-4404
- [email protected]