EndoTNeedle ET1321

GUDID 10816207021147

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
Primary Device ID10816207021147
NIH Device Record Keyf4274e0f-fd02-4314-9375-a58d39f0f61c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTNeedle
Version Model NumberET1321
Catalog NumberET1321
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

Device Dimensions

Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 Gauge
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter2.5 Millimeter
Length230 Centimeter
Needle Gauge23 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816207021140 [Primary]
GS110816207021147 [Package]
Contains: 00816207021140
Package: Box [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-11
Device Publish Date2019-12-03

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