EXEL U-40 1mL INS SYR 29GX1/2" 26037

GUDID 10020221260370

EXEL U-40 1mL INS SYR 29GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN

Exel International

Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic
Primary Device ID10020221260370
NIH Device Record Key5c85f5f9-5cd6-4776-9ca1-73af0dfd6885
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL U-40 1mL INS SYR 29GX1/2"
Version Model Number26037
Catalog Number26037
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100020221260373 [Primary]
GS110020221260370 [Package]
Contains: 00020221260373
Package: Bag [10 Units]
In Commercial Distribution
GS120020221260377 [Package]
Package: Inner box [10 Units]
In Commercial Distribution
GS130020221260374 [Package]
Contains: 20020221260377
Package: Outer box [5 Units]
In Commercial Distribution
GS140020221260371 [Package]
Contains: 30020221260374
Package: Shipping carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

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