Identity
- Trade Name
- FibriJet FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
- Device Name
- Case 250 (bulk) individually pouched AMS600 devices corresponding to pouch UDI-DI 00815634021471 FDA UDI
- Model / Reference
- AMS600-B FDA UDI
- Description
- Case 250 (bulk) individually pouched AMS600 devices corresponding to pouch UDI-DI 00815634021471 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30815634021472 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 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: Open-surgery adhesive/sealant applicator, dual-channel
FibriJet by Micromedics, Inc. — Class I — 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
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 I | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
Sources (1)
- FDA UDI ec647e3b-963d-442e-95bd-4b2b1127e4bd 33 fields · synced Jun 7, 2026