AccessGUDID - DEVICE: Phoenix Elastics (05060772892581)

GUDID

Device Identifier (DI) Information

Brand Name: Phoenix Elastics
Version or Model: E-450-NBE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E-450-NBE
Company Name: PHOENIX ORTHODONTICS INC

Primary DI Number: 05060772892581
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2024
Device Count: 100
Labeler D-U-N-S® Number*: 002092976 *Terms of Use

Device Description: LATEX NEON BLUE E 3-8 HEAVY 4.5 OZ ELASTICS 100 Patient Packs

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?
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
Storage Environment Temperature: between 6 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e786f1b-be5c-49af-a744-c1d81ccc67e6
Public Version Date: August 26, 2024
Public Version Number: 3
DI Record Publish Date: August 17, 2020