AccessGUDID - DEVICE: ASPIJECT SELF ASPIRATING SYRINGE (00303620000000)

GUDID

Device Identifier (DI) Information

Brand Name: ASPIJECT SELF ASPIRATING SYRINGE
Version or Model: 01N2020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01N2020
Company Name: SEPTODONT, INC

Primary DI Number: 00303620000000
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):	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?
12132	Syringe-loaded medication/vaccine injector, manual, professional	A hand-held, manually-powered mechanical device intended to be used in conjunction with a standard plunger syringe and needle to administer an injection of medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. The delivered medication/vaccine is supplied from the prefilled syringe that is loaded into the injector, which is typically a spring-loaded mechanical assembly. It is intended for use by a healthcare professional when serial injections are provided (e.g., mass inoculation); it is not a hypodermic syringe. 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 [?]
K002168	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: 90619938-0908-4c32-838b-acee17293c7d
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 15, 2016