GOMCO CIRCUMCISION CLAMP

GUDID B099540396B0

BLACK GOMCO CIRCUMCISION CLAMP

SONTEC INSTRUMENTS, INC.

Surgical penis clamp, reusable

• Primary Device ID: B099540396B0
• NIH Device Record Key: 8ea10c42-cc8b-4064-8422-9325f83805f5
• Commercial Distribution Discontinuation: 2018-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GOMCO CIRCUMCISION CLAMP
• Version Model Number: 540-396B
• 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

• Lumen/Inner Diameter: 16 Millimeter
• Lumen/Inner Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B099540396B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040052

FDA Product Code

• HFX: Clamp, Circumcision

Sterilization

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

[B099540396B0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B099540396B0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [GOMCO CIRCUMCISION CLAMP ]

• B0995403960: GOMCO CIRCUMCISION CLAMP CHROME
• B099540394B0: BLK GOMCO CIRCUMCISION CLAMP
• B0995403940: GOMCO CIRCUMCISION CLAMP CHROME
• B099540392B0: BLACK GOMCO CIRCUMCISION CLAMP
• B0995403920: GOMCO CIRCUMCISION CLAMP CHROME
• B099540390B0: BLACK GOMCO CIRCUMCISION CLAMP CHROME
• B099540388B0: BLACK GOMCO CIRCUMCISION CLAMP
• B099540396B0: BLACK GOMCO CIRCUMCISION CLAMP
• B0995403890: GOMCO CIRCUMCISION CLAMP CHROME