AccessGUDID - DEVICE: Stabident (05060489370136)

GUDID

Device Identifier (DI) Information

Brand Name: Stabident
Version or Model: Stabident Standard kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST
Company Name: FAIRFAX MEDICAL PRODUCTS LIMITED

Primary DI Number: 05060489370136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 227221793 *Terms of Use

Device Description: Dental anaesthesia injection kit

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:	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?
45152	Dental anaesthesia injection kit	A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZA	Drill, Dental, Intraoral

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: Yes
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: cf7dcd8a-2d68-49bc-88f4-70cfd22fe47d
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023