AccessGUDID - DEVICE: SOPIRA CITOJECT PLASTIC SLEEVE 1.8ML 1PC (J014660054190)

GUDID

Device Identifier (DI) Information

Brand Name: SOPIRA CITOJECT PLASTIC SLEEVE 1.8ML 1PC
Version or Model: 66005419
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66005419
Company Name: Kulzer GmbH

Primary DI Number: J014660054190
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Syringe,cartridge

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?
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
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: 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: 3bc0ce30-2c47-4a17-aa3c-f785aea62716
Public Version Date: October 30, 2024
Public Version Number: 4
DI Record Publish Date: September 15, 2016