Identity
- Trade Name
- Baxter FDA UDI
- Generic Name
- Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
- Device Name
- Endoscopic Applicator, 41 cm FDA UDI
- Model / Reference
- 0600225 FDA UDI
- Description
- Endoscopic Applicator, 41 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634021488 FDA UDI
- 510(k) Number
- K241739 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Fibrin sealant biochemical preparation/application kit, endoscopic
Baxter by Micromedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrin sealant biochemical preparation/application kit, endoscopic.
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- Duplospray — Micromedics, Inc. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
Sources (1)
- FDA UDI 442234c3-5124-48b1-9a3a-26b9d799b9d4 34 fields · synced May 30, 2026