Identity
- Trade Name
- Arthrex® FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- Grspr, LB Tp, 4.2x220 St, NR w/FlushPort FDA UDI
- Model / Reference
- AR-16400NRF FDA UDI
- Description
- Grspr, LB Tp, 4.2x220 St, NR w/FlushPort FDA UDI
Identifiers
- Catalog Number
- AR-16400NRF FDA UDI
- Primary DI / UDI-DI
- 00888867274907 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing unit, reusable
Arthrex's Grspr, LB Tp, 4.2x220 St, NR w/FlushPort is a non-powered, hand-held device designed for suturing and surgical procedures. It features a pointed/cutting component to create a suture tunnel, a reusable design, and a variety of attachments including hooks, catches, clasps, forceps-like jaws at the distal end, and a proximal handle with controls.
Similar devices
Also classified as Suturing unit, reusable.
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- Sklar — Sklar Corporation · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Arthrex, Inc.
Sources (1)
- FDA UDI 13f71fe8-0535-4671-8dc4-ac9e1906dab7 35 fields · synced Jun 23, 2026