00711813

GUDID 10724995180901

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
Primary Device ID10724995180901
NIH Device Record Key63aa0f8c-0e7f-44c4-9c43-1f755a6e923d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number00711813
Catalog Number00711813
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
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

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
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
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
GS100724995180904 [Primary]
GS100816765011911 [Previous]
GS110724995180901 [Package]
Contains: 00724995180904
Package: Box [5 Units]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

Devices Manufactured by US Endoscopy

00724995244545 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244552 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three
00724995244569 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244576 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244583 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244590 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre
00724995244606 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progressive stage balloon capable of th
00724995244613 - Lumiflex2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.