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Silon-TSR 5x5

FDA UDI

Class U (US FDA UDI)

by Bio Med Sciences, Inc.

Identity

Trade Name
Silon-TSR 5x5 FDA UDI
Generic Name
Synthetic polymer semi-permeable film dressing, wound-nonadherent FDA UDI
Device Name
Perforated Temporary Skin Replacement FDA UDI
Model / Reference
2025P FDA UDI
Description
Perforated Temporary Skin Replacement FDA UDI

Identifiers

Catalog Number
2025P FDA UDI
Primary DI / UDI-DI
00810050460019 FDA UDI
510(k) Number
K923150 FDA UDI
FDA Product Code
MGP FDA UDI
GMDN Term
Synthetic polymer semi-permeable film dressing, wound-nonadherent 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

No

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
Width — 5 Inch FDA UDI
Length — 5 Inch FDA UDI
Width — 13 Centimeter FDA UDI
Length — 13 Centimeter FDA UDI

Category: Synthetic polymer semi-permeable film dressing, wound-nonadherent

Silon-TSR 5x5 by Bio Med Sciences, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic polymer semi-permeable film dressing, wound-nonadherent.

Cleared under the same submission

K923150 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio Med Sciences, Inc.

Sources (1)

  • FDA UDI 05481a57-0ed1-4433-8f25-c180dcd4d9f5 37 fields · synced May 30, 2026