Identity
- Trade Name
- Duploject Easy Prep FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
- Device Name
- Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (10 mL Kit) FDA UDI
- Model / Reference
- 1501252 FDA UDI
- Description
- Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel Two-component Fibrin Sealant (10 mL Kit) FDA UDI
Identifiers
- Catalog Number
- 1501252 FDA UDI
- Primary DI / UDI-DI
- 00085412095639 FDA UDI
- 510(k) Number
- K020666 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Open-surgery adhesive/sealant applicator, dual-channel
Duploject Easy Prep by Baxter International 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.
- DUPLOTIP — Micromedics, Inc. · Class II
- PREVELEAK SURGICAL SEALANT — Baxter Healthcare Corp · Class III
- Gasless Tip — Micromedics, Inc. · Class II
- DUPLOTIP — Micromedics, Inc. · Class II
- FibriJet — Micromedics, Inc. · Class I
- Pramand — Micromedics, Inc. · Class II
- DUPLOTIP — Micromedics, Inc. · Class II
- Coseal Surgical Sealant Extended Applicator — Baxter Healthcare Corp · Class III
Cleared under the same submission
K020666 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI b0c44041-359f-4e82-8573-3a07b6b2d53b 37 fields · synced May 29, 2026