Endoscopic Injection Needle 101087

GUDID 10858015005940

Endoscopic Injection Needle

Carbon Medical Technologies, Inc.

General-purpose endoscopic needle, single-use

• Primary Device ID: 10858015005940
• NIH Device Record Key: f30b09bd-cca6-4f1a-9c07-3a63356bc263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoscopic Injection Needle
• Version Model Number: 101087
• Catalog Number: 101087
• Company DUNS: 883094039
• Company Name: Carbon Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8882070262
• Email: info@carbonmed.com

Device Dimensions

• Length: 140 Centimeter
• Length: 140 Centimeter
• Length: 140 Centimeter
• Length: 140 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858015005943 [Primary]
GS1	10858015005940 [Package]; Contains: 00858015005943; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172227

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-25

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