BIOPSY CUP INSERT

GUDID B09929011250

BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Open-surgery biopsy forceps, reusable

• Primary Device ID: B09929011250
• NIH Device Record Key: 6c206132-05c0-4f75-95b1-5ee997da284d
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIOPSY CUP INSERT
• Version Model Number: 2901-125
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 360 Millimeter
• Device Size Text, specify: 0
• Length: 360 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B09929011250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B09929011250]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09929011250]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [BIOPSY CUP INSERT]

• B0992901127S0: BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT
• B09929011110: BIOPSY CUP WITHOUT THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B0992901129S0: BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
• B0992901129L0: BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
• B09929011290: BIOPSY CUP LONG WITH THORN SINGLE-ACTION JAWS FOR TUBE SHAFT
• B0992901127L0: BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT
• B09929011270: BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SAHFT
• B0992901125S0: BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B0992901125L0: BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B09929011250: BIOPSY CUP WITH THORN DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B0992901123S0: BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B0992901123L0: BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B09929011230: BIOPSY CUP DOUBLE-ACTION JAWS FOR TUBE SHAFT