Identity
- Trade Name
- Hemopro 2 w/Vasoshield FDA UDI
- Generic Name
- Flexible endoscopic scissors, reusable FDA UDI
- Device Name
- Hemopro 2 w/Vasoshield FDA UDI
- Model / Reference
- VH-4001 FDA UDI
- Description
- Hemopro 2 w/Vasoshield FDA UDI
Identifiers
- Catalog Number
- VH-4001 FDA UDI
- Primary DI / UDI-DI
- 00607567700451 FDA UDI
- 510(k) Number
- K101274 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Flexible endoscopic scissors, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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: Flexible endoscopic scissors, reusable
Hemopro 2 w/Vasoshield by Maquet Cardiovascular LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic scissors, reusable.
- Scissors — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class I
- Edoscopic Dissection Probe — Medtronic PS Medical · Class II
- ELMED — ELMED INCORPORATED · Class I
- Gyrus ACMI — Gyrus Acmi, Inc. · Class I
- ELMED — ELMED INCORPORATED · Class I
- HYSAFE — Richard Wolf GmbH · Class II
- ELMED — ELMED INCORPORATED · Class I
Cleared under the same submission
K101274 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
Sources (2)
- FDA UDI 8cbebde3-a872-4e1a-836a-7ebab678c0e6 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026