DEVICE: ASPIJECT SELF ASPIRATING SYRINGE (00303620000000)

Device Identifier (DI) Information

ASPIJECT SELF ASPIRATING SYRINGE
01N2020
In Commercial Distribution
01N2020
SEPTODONT, INC
00303620000000
GS1

1
012925513 *Terms of Use
Dental cartridge syringe
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Syringe-loaded 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) or subcutaneously. 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.
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FDA Product Code

[?]
Product Code Product Code Name
EJI Syringe, Cartridge
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002168 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 1.8 Milliliter
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Device Record Status

90619938-0908-4c32-838b-acee17293c7d
July 06, 2018
3
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
(303) 665-7535
usregulatoryaffairs@septodont.com
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