EXEL 0.3mL INS SYR 28GX1/2" 26017

GUDID 10020221260172

EXEL 0.3mL INS SYR 28GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN

Exel International

Insulin syringe/needle, basic
Primary Device ID10020221260172
NIH Device Record Keyc112360b-19c8-4d81-ab29-a09d92b00fff
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL 0.3mL INS SYR 28GX1/2"
Version Model Number26017
Catalog Number26017
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
GS100020221260175 [Primary]
GS110020221260172 [Package]
Contains: 00020221260175
Package: Bag [10 Units]
In Commercial Distribution
GS120020221260179 [Package]
Package: Inner box [10 Units]
In Commercial Distribution
GS130020221260176 [Package]
Contains: 20020221260179
Package: Outer box [5 Units]
In Commercial Distribution
GS140020221260173 [Package]
Contains: 30020221260176
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 Date2023-03-28
Device Publish Date2023-03-20

Devices Manufactured by Exel International

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00020221062809 - EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL2025-10-07 EXEL 20-25mL SYR ONLY L-L BULK NON STERILE, NO PRINT ON BARREL; 500/BAG, 1000/CRTN
00020221063004 - EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER S2025-10-07 EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER STOP, DOUBLE BAGGED, 100/BX, 400/CRTN.
00020221162011 - 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL;2025-10-07 3ML LUER SLIP BARREL, BULK NON-STERILE, NO PRINT ON THE BARREL; 2,000PC/DOUBLE PE BAG/CRTN
00020221163001 - EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL2025-10-07 EXEL 50-60mL SYR BARREL L-L BULK NON STERILE; NO PRINT ON THE BARREL ; 140/BOX, 560/CRTN
00020221464146 - EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED2025-10-07 EXEL HYPO NDL 21GX1"; BULK, NON-STERILE, NON-SILICONIZED; 20,000PCS / CASE (2X10k DOUBLE BAGS)
00020221660487 - EXEL 1mL TB SYR ONLY,BULK,N-S 2025-10-07 EXEL 1mL TB SYR ONLY,BULK,N-S 2000/BAG, 4,000/CS
00020221660494 - EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2025-10-07 EXEL 1mL SYR ONLY LUER LOCK, LDS GASKET, BULK, NON-STERILE 2000/BAG, 4000/CS

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