Identity
- Trade Name
- Novaclips FDA UDI
- Generic Name
- Surgical bulldog clamp, single-use FDA UDI
- Device Name
- Vascular Clamp FDA UDI
- Model / Reference
- N-10113 FDA UDI
- Description
- Vascular Clamp FDA UDI
Identifiers
- Catalog Number
- N-10113 FDA UDI
- Primary DI / UDI-DI
- 00852621004031 FDA UDI
- 510(k) Number
- K000098 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Surgical bulldog clamp, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical bulldog clamp, single-use
Novaclips by Vitalitec International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical bulldog clamp, single-use.
- KİNG — İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. · Class III
- Vascular Tourniquet Set, 1 Snare, 5 Tubes — DİSPOSET TIBBİ ÜRÜNLER SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class IIa
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Scanlan® VASCU-STATT® Plus aprox s-use bulldog clamp w/Gentle-Jaw™ surface — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30C — BrosMed Medical Co., Ltd. · Class I
- Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa
- Scanlan® VASCU-STATT® approximator single-use bulldog clamp — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
Cleared under the same submission
K000098 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Vitalitec International, Inc.
Sources (1)
- FDA UDI fa1cd512-de76-4416-b807-348d9230a665 36 fields · synced Jun 6, 2026