EndoTNeedle ET1301

GUDID 10816207021055

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 ID10816207021055
NIH Device Record Key3ceb9bc1-e0f2-4383-97d0-d8b2b42b56e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoTNeedle
Version Model NumberET1301
Catalog NumberET1301
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 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
GS100816207021058 [Primary]
GS110816207021055 [Package]
Contains: 00816207021058
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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-14

On-Brand Devices [EndoTNeedle]

10816207021062Endoscopic injection needle
10816207021055Endoscopic injection needle
10816207021031Endoscopic injection needle
10816207021017Endoscopic injection needle
10816207020171Endoscopic injection needle
10816207021161Endoscopic injection needle
10816207021154Endoscopic injection needle
10816207021147Endoscopic injection needle
10816207021130Endoscopic injection needle
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.