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Preveleak Surgical Sealant

FDA UDI

Class III (US FDA UDI)

by Baxter Healthcare Corp

Identity

Trade Name
PREVELEAK SURGICAL SEALANT FDA UDI
Generic Name
Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Device Name
The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products. FDA UDI
Model / Reference
ADS201807 FDA UDI
Description
The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products. FDA UDI

Identifiers

Catalog Number
ADS201807 FDA UDI
Primary DI / UDI-DI
05413765583520 FDA UDI
PMA Number
P100030 FDA UDI
FDA Product Code
NBE FDA UDI
GMDN Term
Open-surgery adhesive/sealant applicator, dual-channel 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

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

Preveleak Surgical Sealant by Baxter Healthcare Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery adhesive/sealant applicator, dual-channel.

Cleared under the same submission

P100030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA UDI 8820c7f1-ae6a-42f5-9e26-49583a94a3d1 37 fields · synced May 30, 2026