AccessGUDID - DEVICE: Monoject (10884521002531)

GUDID

Device Identifier (DI) Information

Brand Name: Monoject
Version or Model: 8881400041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8881400041
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521002531
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 100
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Dental Needle,Plastic Hub,25 G Short

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):	No
Over the Counter (OTC):	Yes
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
Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Needle Gauge,25,Gauge;
Length: 0.75 Inch

Device Record Status

Public Device Record Key: c5ca1621-a97d-4f19-9426-c423acff05ff
Public Version Date: January 08, 2025
Public Version Number: 3
DI Record Publish Date: June 30, 2018