AccessGUDID - DEVICE: PLUNGER FOR PAROJECT-HF02500A1 (00303620000031)

GUDID

Device Identifier (DI) Information

Brand Name: PLUNGER FOR PAROJECT-HF02500A1
Version or Model: 01N2042
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEPTODONT, INC

Primary DI Number: 00303620000031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012925513 *Terms of Use

Device Description: Spare part for 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 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
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: f161a04f-e160-45f4-8359-21ee8312146f
Public Version Date: November 22, 2018
Public Version Number: 4
DI Record Publish Date: September 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (303) 665-7535
Email: usregulatoryaffairs@septodont.com

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