AccessGUDID - DEVICE: Separators (00190746034411)

GUDID

Device Identifier (DI) Information

Brand Name: Separators
Version or Model: 854-251
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 854-251
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746034411
Issuing Agency: GS1
Commercial Distribution End Date: July 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: ELASTOMERIC SEPARATOR X-RING TEAL LG 080 ID 1040 SEPS/PKG

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):	Yes
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?
63708	Orthodontic separator	A non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	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 Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 2 and 38 Degrees Celsius
Special Storage Condition, Specify: Keep Away from Light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b74f5695-94b7-4e3c-9f80-2f2661466213
Public Version Date: July 25, 2022
Public Version Number: 5
DI Record Publish Date: May 16, 2019