EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL 26280BNP

GUDID 10020221062806

EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL; 500/BAG, 1000/CRTN

Exel International

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use
Primary Device ID10020221062806
NIH Device Record Keyfc960ff2-ad75-4f74-b93b-5e1eaaf6b795
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL
Version Model Number26280BNP
Catalog Number26280BNP
Company DUNS180572216
Company NameExel International
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100020221062809 [Primary]
GS110020221062806 [Package]
Contains: 00020221062809
Package: BAG [500 Units]
In Commercial Distribution
GS120020221062803 [Package]
Package: Shipping carton [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

[10020221062806]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-13
Device Publish Date2023-04-05

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