Endoscopic injection needle SN-1623-22

GUDID 10816207020942

Endoscopic injection needle

ENDO-THERAPEUTICS, INC.

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use
Primary Device ID10816207020942
NIH Device Record Key95a1f992-e7a7-4e5d-a6ae-4a9d32977706
Commercial Distribution Discontinuation2019-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEndoscopic injection needle
Version Model NumberSN-1623-22
Catalog NumberSN-1623-22
Company DUNS825239189
Company NameENDO-THERAPEUTICS, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com
Phone844-400-3636
Emailcustomerservice@endotherapeutics.com

Device Dimensions

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Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length230 Centimeter
Outer Diameter2.3 Millimeter
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100816207020945 [Primary]
GS110816207020942 [Package]
Contains: 00816207020945
Package: Box [10 Units]
Discontinued: 2019-11-04
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBKEndoscopic Injection Needle, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-05
Device Publish Date2018-05-14

Devices Manufactured by ENDO-THERAPEUTICS, INC.

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10816207021352 - RotoNet2023-07-19 Endoscopic Retrieval Net - Standard, Enteroscope
10816207021369 - RotoNet2023-07-19 Endoscopic Retrieval Net - Maxi, Esophageal
10816207021376 - RotoNet2023-07-19 Endoscopic Retrieval Net - Maxi, Colonic
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