AccessGUDID - DEVICE: Ultra-Thin Silicone Nipple Shields

GUDID

Device Identifier (DI) Information

Brand Name: Ultra-Thin Silicone Nipple Shields - M
Version or Model: MHK003-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THINK GREEN LIMITED

Primary DI Number: 09420060202045
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?
43272	Nipple pad/ring, reusable	A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFS	Shield, Nipple

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: a7b4062c-ed6d-4ee4-88e6-581ca82e87ec
Public Version Date: December 24, 2024
Public Version Number: 1
DI Record Publish Date: December 16, 2024