AccessGUDID - DEVICE: PAROJECT (00303620000024)

GUDID

Device Identifier (DI) Information

Brand Name: PAROJECT
Version or Model: 01N2040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01N2040
Company Name: SEPTODONT, INC

Primary DI Number: 00303620000024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012925513 *Terms of Use

Device Description: Dental cartridge syringe

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

[?]

Product Code	Product Code Name
EGM	Injector, Jet, Mechanical-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904279	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.8 Milliliter

Device Record Status

Public Device Record Key: ad353efc-a3da-42de-a7ec-32c4f9e0dd8b
Public Version Date: November 22, 2018
Public Version Number: 4
DI Record Publish Date: September 15, 2016