AccessGUDID - DEVICE: MAMMOGRAPHY GOWN (00634916457643)

GUDID

Device Identifier (DI) Information

Brand Name: MAMMOGRAPHY GOWN
Version or Model: 74347089
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74347089
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916457643
Issuing Agency: GS1
Commercial Distribution End Date: September 13, 2019
Device Count: 48
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves, single metal snap at front opening, OSFA

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11905	Patient gown, reusable	A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FME	Gown, Examination

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc96adec-0087-4544-84be-bc940e52d039
Public Version Date: July 03, 2023
Public Version Number: 2
DI Record Publish Date: May 03, 2018