AccessGUDID - DEVICE: Silicone Crown and Palm Teether Set (09420060210033)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Crown and Palm Teether Set
Version or Model: AMZ140
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THINK GREEN LIMITED

Primary DI Number: 09420060210033
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2060
Device Count: 1
Labeler D-U-N-S® Number*: 595005923 *Terms of Use

Device Description: No description.

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":	Yes
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?
10243	Infant care kit	A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEF	Ring, Teething, Non-Fluid Filled

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: 770227d4-d857-4f5f-8224-f2751cf42bcc
Public Version Date: December 25, 2024
Public Version Number: 1
DI Record Publish Date: December 17, 2024