AccessGUDID - DEVICE: E.M Adams co, inc. (18100013400800)

GUDID

Device Identifier (DI) Information

Brand Name: E.M Adams co, inc.
Version or Model: 114-3184-1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: E.M. ADAMS, INC.

Primary DI Number: 18100013400800
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: CIRCUMCISION TRAY

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
34945	Circumcision kit, single-use	A collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHG	Circumcision Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 8.75" X 7" X 1.25"

Device Record Status

Public Device Record Key: 1cbe0bee-83c8-465c-b692-9e14430caa4a
Public Version Date: March 01, 2021
Public Version Number: 3
DI Record Publish Date: December 31, 2019