Identity
- Trade Name
- ETHICON FDA UDI
- Generic Name
- Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use FDA UDI
- Device Name
- Laparoscopic Dual Flexible Applicator FDA UDI
- Model / Reference
- VSTL45 FDA UDI
- Description
- Laparoscopic Dual Flexible Applicator FDA UDI
Identifiers
- Catalog Number
- VSTL45 FDA UDI
- Primary DI / UDI-DI
- 10705031462724 FDA UDI
- FDA Product Code
- MZM FDA UDI
- GMDN Term
- Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Ethicon by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use.
- Spine Needle (18 Gauge) — ELLIQUENCE LLC · Class II
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- PDO Max Cannulas — Max Pdo Inc · Class I
- PDO Max Cannulas — Max Pdo Inc · Class I
- PDO Max Cannula — Max Pdo Inc · Class I
- Reprocessed Universal Cannula Set Without Fenestration — SURETEK MEDICAL · Class I
- EndoClot Applicator — EndoClot Plus, Inc. · Class II
- ETHICON — Ethicon Inc. · Class II
Cleared under the same submission
BK190324 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
- Ethicon Inc.
Sources (1)
- FDA UDI eb5a5f9c-b035-401d-af33-0223d3f64e47 36 fields · synced May 31, 2026