AccessGUDID - DEVICE: Ultra Safety Plus Twist 25G Long (03701398101870)

GUDID

Device Identifier (DI) Information

Brand Name: Ultra Safety Plus Twist 25G Long
Version or Model: 01N4452
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01N4452
Company Name: SEPTODONT SAS SPECIALITES SEPTODONT

Primary DI Number: 03701398101870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 101
Labeler D-U-N-S® Number*: 275273795 *Terms of Use

Device Description: 100 needles with one sterilisable handle

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?
12740	Dental syringe needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.	Active	false
35969	Dental anaesthesia syringe, reusable	A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZM	Needle, Dental
EJI	Syringe, Cartridge

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95ac9718-3278-4aad-9b36-f578647f1d31
Public Version Date: September 26, 2022
Public Version Number: 2
DI Record Publish Date: December 23, 2020