00711814

GUDID 10816765011925

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 ID: 10816765011925
• NIH Device Record Key: d05476b8-9be7-4f0b-ba88-4c1ce81eceee
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 00711814
• Catalog Number: 00711814
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge
• Length: 230 Centimeter
• Outer Diameter: 2.5 Millimeter
• Needle Gauge: 23 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765011928 [Primary]
GS1	10816765011925 [Package]; Contains: 00816765011928; Package: Box [5 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971842

FDA Product Code

• FCG: Biopsy needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-17

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• 00724995244583 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre
• 00724995244590 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre
• 00724995244606 - Lumiflex: 2025-06-11 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 - Lumiflex: 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th