AccessGUDID - DEVICE: MAMMOGRAM CAPE (00634916677805)

GUDID

Device Identifier (DI) Information

Brand Name: MAMMOGRAM CAPE
Version or Model: 74405480
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 74405480
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916677805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: Mammography Cape. Front Closure, 3/4 Length Sleeves Set In, White Bias Binding, White Twill Ties at Waist on Inside and Outside, 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: 8e89d030-f9b5-4787-9539-a3e8bbc93b83
Public Version Date: April 13, 2020
Public Version Number: 1
DI Record Publish Date: April 03, 2020