Identity
- Trade Name
- Ziploop® FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Model / Reference
- 904794 FDA UDI
Identifiers
- Catalog Number
- 904794 FDA UDI
- Primary DI / UDI-DI
- 00887868511134 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suturing unit, single-use
Ziploop® by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
- eXact 5.1 — Cypris Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- 25° Left, Champion®+ Slider with Nitinol Passing Wire — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- JUGGERKNOT SOFT ANCHORS — Biomet Sports Medicine · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 83f161d1-b81c-49c2-a79b-c29f1d03c319 34 fields · synced Jun 6, 2026