Identity
- Trade Name
- FIBRIJET FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
- Device Name
- MANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 20CM, 11:1 RATIO FDA UDI
- Model / Reference
- SA-3664 FDA UDI
- Description
- MANUAL ENDOSCOPIC SPRAY APP.W/MIX TIP 5MM X 20CM, 11:1 RATIO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634020160 FDA UDI
- 510(k) Number
- K042834 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel 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
No
FDA UDI
Category: Open-surgery adhesive/sealant applicator, dual-channel
Fibrijet by Micromedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery adhesive/sealant applicator, dual-channel.
- PREVELEAK SURGICAL SEALANT — Baxter Healthcare Corp · Class III
- Coseal Surgical Sealant Extended Applicator — Baxter Healthcare Corp · Class III
- Flow Regulator — Covidien LP · Class I
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- Duploject Easy Prep — BAXTER INTERNATIONAL INC. · Class II
- DUPLOCATH — BAXTER INTERNATIONAL INC. · Class II
- Extended Tip Applicator — Integra Lifesciences Corp. · Class II
- TISSEEL/ARTISS SPRAY SET — Baxter Healthcare Corp · Class II
Cleared under the same submission
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 6298e193-9f15-4fde-9efa-0913d42be307 34 fields · synced Jun 8, 2026