3ML LATEX-FREE LDS GASKET, BULK NON-STERILE 26201DG

GUDID 10020221062011

3ML LATEX-FREE LDS GASKET, BULK NON-STERILE; 20,000PC/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 ID10020221062011
NIH Device Record Key15ef3c5d-225f-4911-956b-d8dd74ef45a5
Commercial Distribution StatusIn Commercial Distribution
Brand Name3ML LATEX-FREE LDS GASKET, BULK NON-STERILE
Version Model Number26201DG
Catalog Number26201DG
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
GS100020221062014 [Primary]
GS110020221062011 [Package]
Contains: 00020221062014
Package: Shipping carton [20000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

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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