00711823

GUDID 10816765012663

The Carr-Locke injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

US Endoscopy

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 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 ID10816765012663
NIH Device Record Keyfac04638-d522-469e-8100-528c56bfad88
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number00711823
Catalog Number00711823
Company DUNS627879687
Company NameUS Endoscopy
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge
Length230 Centimeter
Outer Diameter2.5 Millimeter
Needle Gauge25 Gauge

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
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
GS100816765012666 [Primary]
GS110816765012663 [Package]
Contains: 00816765012666
Package: Box [10 Units]
Discontinued: 2020-03-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-31
Device Publish Date2016-09-17

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50724995220681 - Assurance2023-03-30 The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purp
10724995220690 - Assurance2023-03-30 The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpo
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