EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER S 26300BNNP

GUDID 10020221063001

EXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER STOP, DOUBLE BAGGED, 100/BX, 400/CRTN.

Exel International

General-purpose syringe, single-use
Primary Device ID10020221063001
NIH Device Record Key5e63d76b-a020-4aea-aeb9-2cc910dac070
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL 50-60mL SYR ONLY L-L BULK NON STERILE; NO PRINT ON THE BARREL, NO PLUNGER S
Version Model Number26300BNNP
Catalog Number26300BNNP
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100020221063004 [Primary]
GS110020221063001 [Package]
Contains: 00020221063004
Package: Inner box [100 Units]
In Commercial Distribution
GS120020221063008 [Package]
Package: Shipping carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


[10020221063001]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

Devices Manufactured by Exel International

10020221260233 - EXEL 1/2mL INS SYR 28GX1/2"2024-12-03 EXEL 1/2mL INS SYR 28GX1/2", 100/BX, 500/CS, 6CS/CRTN
20020221260032 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 29G x 1/2
20020221260049 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/4
20020221260056 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/3
20020221260063 - EXEL Comfort Point Insulin Pen Needles2024-06-26 Insulin Pen Needle, 31G x 1/6
10020221277644 - Exel SecureTouch Safety Blood Collection Set2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
00020221277661 - Exel SecureTouch Safety Blood Collection Set2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
00020221277685 - Exel SecureTouch Safety Blood Collection Set2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.