AccessGUDID - DEVICE: Premium Rubber Helmet Condoms (00850016109705)

GUDID

Device Identifier (DI) Information

Brand Name: Premium Rubber Helmet Condoms
Version or Model: SCLF-52050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scutagli, LLC

Primary DI Number: 00850016109705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 078668294 *Terms of Use

Device Description: Lifestyles Snugger Fit with Premium Rubber Helmet Condoms Silver Pocket Case - 50 Bulk Count

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):	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?
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIS	Condom

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994095	000

Device Exempt from Premarket Submission: No 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: bb127da0-90d6-44c1-9c87-ae4529493c44
Public Version Date: November 17, 2023
Public Version Number: 1
DI Record Publish Date: November 09, 2023