AccessGUDID - DEVICE: Ripelicator (00860004725107)

GUDID

Device Identifier (DI) Information

Brand Name: Ripelicator
Version or Model: RIP-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RIP-01
Company Name: Huck Medical Technologies, Inc.

Primary DI Number: 00860004725107
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2026
Device Count: 10
Labeler D-U-N-S® Number*: 049583329 *Terms of Use

Device Description: Vaginal applicator, single-use: A device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
Prescription Use (Rx):	Yes
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?
37448	Vaginal applicator, single-use	A device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGD	Applicator, Vaginal

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: 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
Shaft Length: 15 Centimeter

Device Record Status

Public Device Record Key: 8f4da95d-8d8b-44d0-bc24-2fb3bb873a44
Public Version Date: August 05, 2021
Public Version Number: 1
DI Record Publish Date: July 28, 2021