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Mammogram Jacket

FDA UDI

Class I (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
MAMMOGRAM JACKET FDA UDI
Generic Name
Patient gown, reusable FDA UDI
Device Name
MAMMOGRAM JACKET HARBOR 5XL WHITE NK BNDG TIES (SR 16669) FDA UDI
Model / Reference
74105858 FDA UDI
Description
MAMMOGRAM JACKET HARBOR 5XL WHITE NK BNDG TIES (SR 16669) FDA UDI

Identifiers

Catalog Number
74105858 FDA UDI
Primary DI / UDI-DI
00634916194203 FDA UDI
FDA Product Code
FME FDA UDI
GMDN Term
Patient gown, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6265 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Patient gown, reusable

Mammogram Jacket by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient gown, reusable.

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 44c928b0-5b71-4461-9b1c-de8d5d690814 35 fields · synced May 31, 2026