AccessGUDID - DEVICE: Denovo chairside space maintainer band (00810059292710)

GUDID

Device Identifier (DI) Information

Brand Name: Denovo chairside space maintainer band
Version or Model: 8385-297
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Denovo Dental, Inc.

Primary DI Number: 00810059292710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183498179 *Terms of Use

Device Description: Denovo chairside space maintainer band - Mandibular size L42

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):	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?
31754	Orthodontic space maintainer	A dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and other complications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYT	Maintainer, Space Preformed, Orthodontic

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: fdcaa753-7359-4375-b2b1-77c788d235f3
Public Version Date: June 30, 2023
Public Version Number: 1
DI Record Publish Date: June 22, 2023