Identity
- Trade Name
- PREVELEAK SURGICAL SEALANT FDA UDI
- Generic Name
- Surgical internal adhesive/sealant, animal-derived FDA UDI
- Device Name
- Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses FDA UDI
- Model / Reference
- ADS201808 FDA UDI
- Description
- Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses FDA UDI
Identifiers
- Catalog Number
- ADS201808 FDA UDI
- Primary DI / UDI-DI
- 05413765583582 FDA UDI
- PMA Number
- P100030 FDA UDI
- FDA Product Code
- NBE FDA UDI
- GMDN Term
- Surgical internal adhesive/sealant, animal-derived FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Category: Surgical internal adhesive/sealant, animal-derived
Preveleak Surgical Sealant by Baxter Healthcare Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical internal adhesive/sealant, animal-derived.
- PreveLeak™ Surgical Sealant — Tenaxis Medical, Inc. · Class III
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- PreveLeak™ 10 pack Tips — Tenaxis Medical, Inc. · Class III
- PreveLeak™ Surgical Sealant — Tenaxis Medical, Inc. · Class III
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- BioGlue Surgical Adhesive — Artivion, Inc. · Class III
- AUVON — Shenzhen Yuwen E-Commerce Co., Ltd. · Class I
- TendoNova Ocelot — TendoNova Corporation · U
Cleared under the same submission
P100030 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 III | Pending data |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA UDI 18d4e3c2-d829-4309-a101-e5a67e798cdd 37 fields · synced May 31, 2026