Circumplast

GUDID 09351108000043

Circumplast 11mm Shipping Carton

EMBOSS MEDICAL LIMITED

Circumcision clamp, single-use

• Primary Device ID: 09351108000043
• NIH Device Record Key: ea54716d-2409-40c4-8184-4641ffaa7a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circumplast
• Version Model Number: Circumplast 11mm Shipping Carton
• Company DUNS: 226185194
• Company Name: EMBOSS MEDICAL LIMITED
• Device Count: 1000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351108000043 [Primary]
GS1	09351108000104 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151095

FDA Product Code

• HFX: Clamp, Circumcision

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2017-10-18

On-Brand Devices [Circumplast]

• 09351108000074: Circumplast 13mm Shipping Carton
• 09351108000067: Circumplast 12mm Shipping Carton
• 09351108000050: Circumplast 9.5mm Shipping Carton
• 09351108000043: Circumplast 11mm Shipping Carton
• 09351108000036: Circumplast single use infant male circumcision device, size 13mm
• 09351108000029: Circumplast single use infant male circumcision device, size 12mm
• 09351108000012: Circumplast single use infant male circumcision device, size 11mm
• 09351108000005: Circumplast single use infant male circumcision device, size 9.5mm