AccessGUDID - DEVICE: Painless Steel ® (ETDG1622412)

GUDID

Device Identifier (DI) Information

Brand Name: Painless Steel ®
Version or Model: 25G 0.5 x 25 mm, short, RW (regular wall), hub and front cap red
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 162241
Company Name: medmix Deutschland GmbH

Primary DI Number: ETDG1622412
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 314320603 *Terms of Use

Device Description: Sterile Single-Use Dental Injection Needles are sterile, disposable, sharp bevel-edged, hollow tubular metal instruments with an integrated hub. Sterile Single-Use Dental Injection Needles should be used in combination with dental cartridge syringes (according to ISO 9997) in which a dental cylinder ampoule according to ISO 11040-1 is inserted.

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?
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

FDA Product Code

[?]

Product Code	Product Code Name
DZM	Needle, Dental

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: 1a3bb39c-a114-4e7c-ba65-14e0fc238150
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022