AccessGUDID - DEVICE: Herbst Mini-Scope Accessories with Hex Screw (00889989087444)

GUDID

Device Identifier (DI) Information

Brand Name: Herbst Mini-Scope Accessories with Hex Screw
Version or Model: 1704-9300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALLESEE AOA-PRO

Primary DI Number: 00889989087444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 158312728 *Terms of Use

Device Description: Herbst Mini-Scope Accessories with Hex Screw

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?
40734	Orthodontic clasp, metal, custom-made	A dental device made of cast metal material intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet the specifications of an individual patient. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJF	BRACKET, METAL, 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: 899c7a95-e003-40c5-9472-7d0ebd578f6f
Public Version Date: December 22, 2022
Public Version Number: 1
DI Record Publish Date: December 14, 2022