EXEL HYPO NDL 16GX1" BULK, NON-STERILIE; "NON SILICONIZED" 26421BNS

GUDID 10020221464211

EXEL HYPO NDL 16GX1" BULK, NON-STERILIE; "NON SILICONIZED"; DOUBLE BAGGED, 5,000PCS/CASE, 20,000PCS/CARTON #777034019 BNNS

Exel International

Hypodermic needle, single-use
Primary Device ID10020221464211
NIH Device Record Key264b368a-81a2-49de-a54d-f66c8acc5c07
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXEL HYPO NDL 16GX1" BULK, NON-STERILIE; "NON SILICONIZED"
Version Model Number26421BNS
Catalog Number26421BNS
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
GS100020221464214 [Primary]
GS110020221464211 [Package]
Contains: 00020221464214
Package: CASE [5000 Units]
In Commercial Distribution
GS120020221464218 [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

[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


[10020221464211]

Ethylene Oxide


Device Entry Metadata

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

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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

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