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Sentrex BioSponge Ultra

FDA UDI

Class U (US FDA UDI)

by Bionova Medical, Inc.

Identity

Trade Name
Sentrex BioSponge Ultra FDA UDI
Generic Name
Cavity-wound management dressing, non-antimicrobial FDA UDI
Model / Reference
500-1010 FDA UDI

Identifiers

Primary DI / UDI-DI
00850047730282 FDA UDI
510(k) Number
K123961 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Cavity-wound management dressing, non-antimicrobial FDA UDI

Classification

Device Class
U 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

Dimensions & Sizes

Size
Length — 10 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

Category: Cavity-wound management dressing, non-antimicrobial

Sentrex BioSponge Ultra by Bionova Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cavity-wound management dressing, non-antimicrobial.

Cleared under the same submission

K123961 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bionova Medical, Inc.

Sources (1)

  • FDA UDI 75d55bfb-1577-49bf-b705-1614fbd9e036 35 fields · synced Jun 8, 2026