Identity
- Trade Name
- VESSEL CLAMP, BLUE FDA UDI
- Generic Name
- Surgical bulldog clamp, single-use FDA UDI
- Device Name
- A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device. FDA UDI
- Model / Reference
- 201003-000 FDA UDI
- Description
- A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 201003-000 FDA UDI
- Primary DI / UDI-DI
- B0662010030000 FDA UDI
- 510(k) Number
- K801395 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
Yes
FDA UDI
Category: Surgical bulldog clamp, single-use
Vessel Clamp, Blue by Novosci Corp. — 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
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- 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
K801395 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
- Novosci Corp.
Sources (1)
- FDA UDI 0f541c45-77ee-47cd-9aef-51e2369ee462 36 fields · synced May 31, 2026