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Barrier Supreme Wrapper

FDA UDI

Class II (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
Barrier Supreme Wrapper FDA UDI
Generic Name
Sterilization packaging, reusable FDA UDI
Device Name
WRAPPER BAR SUP 18X18 KAUM CBL - RM (98 7447) USE: 21651502 FDA UDI
Model / Reference
216515E5 FDA UDI
Description
WRAPPER BAR SUP 18X18 KAUM CBL - RM (98 7447) USE: 21651502 FDA UDI

Identifiers

Catalog Number
216515E5 FDA UDI
Primary DI / UDI-DI
00634916074970 FDA UDI
510(k) Number
K162162 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

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

Cleared under the same submission

K162162 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 4d9ff44d-7b6d-4719-9574-f2f42036d478 37 fields · synced Jun 8, 2026