FDA.report

Septodont

Primary DI
00841685100353
Brand
Septodont
Company
A. TITAN INSTRUMENTS, INC.
Model
N-2100
Device description
Aspirating Syringe Small Blue Septodont USA
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJISyringe, Cartridge

Product Code Classifications

CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841685100353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841685100353008416851003538416851003530841685100353

GMDN Terms

TermDefinition
Syringe-loaded injector, manual, professionalA 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.

Sterilization Methods

Method
Dry Heat Sterilization

Regulatory Flags

DUNS number
037738874
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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