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PreveLeak™ 10 pack Tips

FDA UDI

Class III (US FDA UDI)

by Tenaxis Medical, Inc.

Identity

Trade Name
PreveLeak™ 10 pack Tips FDA UDI
Generic Name
Surgical internal adhesive/sealant, animal-derived FDA UDI
Device Name
Accessory tips for PreveLeak™ Surgical Sealant FDA UDI
Model / Reference
10 pack Tips FDA UDI
Description
Accessory tips for PreveLeak™ Surgical Sealant FDA UDI

Identifiers

Catalog Number
8003 FDA UDI
Primary DI / UDI-DI
00850868002056 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

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: Surgical internal adhesive/sealant, animal-derived

PreveLeak™ 10 pack Tips by Tenaxis Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical internal adhesive/sealant, animal-derived.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenaxis Medical, Inc.

Sources (1)

  • FDA UDI 002bd2fb-d421-4ac2-8f31-df32a25f9c63 35 fields · synced May 30, 2026