AccessGUDID - DEVICE: E.M Adams co, inc. (18100013410427)

GUDID

Device Identifier (DI) Information

Brand Name: E.M Adams co, inc.
Version or Model: EP9039-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 18100013410427
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 001403807 *Terms of Use

Device Description: ABDOMINAL BINDER

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
10003	Abdominal binder, single-use	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSD	Binder, Abdominal

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
Device Size Text, specify: 9" X 42"

Device Record Status

Public Device Record Key: 087d533e-b396-43ea-8139-8294938aea16
Public Version Date: March 01, 2021
Public Version Number: 3
DI Record Publish Date: December 31, 2019