AccessGUDID - DEVICE: Creatures of the Sea (00190730032805)

GUDID

Device Identifier (DI) Information

Brand Name: Creatures of the Sea
Version or Model: 500-203LF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ORTHO TECHNOLOGY, INC.

Primary DI Number: 00190730032805
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 781772017 *Terms of Use

Device Description: Elastics Non-Latex Med. 1/4" Seal 50 pks of 100

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):	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?
62074	Orthodontic inter-arch elastic band	A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECI	BAND, ELASTIC, 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: 4638edb5-d5fd-4171-9e8b-90306f0a01b7
Public Version Date: September 03, 2021
Public Version Number: 2
DI Record Publish Date: May 15, 2019