BIOPSY CUP INSERT

GUDID B0992901127S0

BIOPSY CUP LONG SINGLE-ACTION JAWS FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: B0992901127S0
• NIH Device Record Key: f9760ea3-a572-442f-bfcb-71a02eac5132
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSY CUP INSERT
• Version Model Number: 2901-127S
• 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
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007451 [Primary]
HIBCC	B0992901127S0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102921

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992901127S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-08
• Device Publish Date: 2018-08-22

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