AccessGUDID - DEVICE: NuSmile UCSM Replacement Band (00810118103483)

GUDID

Device Identifier (DI) Information

Brand Name: NuSmile UCSM Replacement Band
Version or Model: RB411/2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NUSMILE, LTD.

Primary DI Number: 00810118103483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185497372 *Terms of Use

Device Description: NuSmile UCSM Replacement Band - Size 41 1/2

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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: 3c49583d-4abb-4afe-91de-9e3852a670be
Public Version Date: March 01, 2023
Public Version Number: 1
DI Record Publish Date: February 21, 2023

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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 713.861.0033
Email: smunoz@nusmile.com

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