EndoTNeedle ET1310

GUDID 10816207020171

Endoscopic injection needle

ENDO-THERAPEUTICS, INC.

General-purpose endoscopic needle, single-use
Primary Device ID10816207020171
NIH Device Record Keyc4052590-a7be-4e4e-ab8e-58a1a3dbd524
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTNeedle
Version Model NumberET1310
Catalog NumberET1310
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
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

Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.3 Millimeter
Length230 Centimeter
Needle Gauge22 Gauge

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
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
GS100816207020174 [Primary]
GS110816207020171 [Package]
Contains: 00816207020174
Package: Case [10 Units]
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 Date2018-07-06
Device Publish Date2016-09-22

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