AccessGUDID - DEVICE: Renew Inserts (00861680000403)

GUDID

Device Identifier (DI) Information

Brand Name: Renew Inserts
Version or Model: FG730
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG730
Company Name: RENEW MEDICAL INC

Primary DI Number: 00861680000403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 967228474 *Terms of Use

Device Description: 30 pack carton of individually packaged Renew regular size single shot Inserts

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":	No
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?
46193	Anal plug, single-use	A device designed to be inserted into the rectum by the user and retained there as a barrier to the passage of stool for the prevention of the involuntary evacuation of stool (faeces) in persons who are incontinent of bowel. It is typically made of plastic foam materials which expand upon contact with rectal moisture; it is available in a variety of sizes. The device may also be known as an anal tampon and is intended to be replaced after each rectal void. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBP	Rectal Insert

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122003	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: e3d0d4c1-d31d-401c-bc39-7c7e1195e1f9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 01, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00861680000441 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-987-2929
Email: ricky@renew-medical.com

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