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Standard Supreme Wrapper (hemmed)

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
Standard Supreme Wrapper (hemmed) FDA UDI
Generic Name
Sterilization packaging, reusable FDA UDI
Device Name
WRAPPER T-180 JADE 35X35 2PLY - HEMMED W/BLUE THREAD FDA UDI
Model / Reference
21533012 FDA UDI
Description
WRAPPER T-180 JADE 35X35 2PLY - HEMMED W/BLUE THREAD FDA UDI

Identifiers

Catalog Number
21533012 FDA UDI
Primary DI / UDI-DI
00634916343212 FDA UDI
510(k) Number
K172207 FDA UDI
FDA Product Code
FRG FDA UDI
GMDN Term
Sterilization packaging, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Standard Supreme Wrapper (hemmed) by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K172207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA UDI 5c7427c1-ac61-4c72-b630-f99c7fb54a4b 37 fields · synced May 31, 2026