Gomco Type Circumcision Clamp 28-857

GUDID 00869401000237

Gomco Type Circumcision Clamp Disposable Chrome Plated, Child 1.6cm

FINE SURGICAL INSTRUMENTS INC.

Circumcision clamp, single-use

• Primary Device ID: 00869401000237
• NIH Device Record Key: ebd61c6d-f503-4e76-96c7-1f65584067b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gomco Type Circumcision Clamp
• Version Model Number: 28-857
• Catalog Number: 28-857
• Company DUNS: 103669727
• Company Name: FINE SURGICAL INSTRUMENTS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(516)292-7400
• Email: mirza@finesurgical.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869401000237 [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

[00869401000237]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

On-Brand Devices [Gomco Type Circumcision Clamp]

• 00869401000275: Gomco Type Circumcision Clamp Stainless Steel (German) Child 1.6cm
• 00869401000268: Gomco Type Circumcision Clamp Stainless Steel (German) Infant 1.45cm
• 00869401000251: Gomco Type Circumcision Clamp Stainless Steel (German) NB 1.3cm
• 00869401000244: Gomco Type Circumcision Clamp Stainless Steel (German) XSML 1.1cm
• 00869401000237: Gomco Type Circumcision Clamp Disposable Chrome Plated, Child 1.6cm
• 00869401000220: Gomco Type Circumcision Clamp Disposable Chrome Plated , Infant 1.45cm
• 00869401000213: Gomco Type Circumcision Clamp Disposable Chrome Plated, NB 1.3cm
• 00869401000206: Gomco Type Circumcision Clamp Disposable Chrome Plated, XSML 1.1cm