TopClosure 1S-SBL8-GI

GUDID 27290111500200

I.V.T. MEDICAL LTD

Skin-closing tension device

• Primary Device ID: 27290111500200
• NIH Device Record Key: 031a2bf1-6243-4efa-a017-5158cc7b2470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopClosure
• Version Model Number: 1S Clinic Pack 8mm
• Catalog Number: 1S-SBL8-GI
• Company DUNS: 514996339
• Company Name: I.V.T. MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290111500206 [Primary]
GS1	17290111500203 [Package]; Contains: 07290111500206; Package: Blister Box [10 Units]; In Commercial Distribution
GS1	27290111500200 [Package]; Contains: 17290111500203; Package: Distribution Carton [10 Units]; In Commercial Distribution

FDA Product Code

• MKY: System, Skin Closure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-13

On-Brand Devices [TopClosure]

• 27290111503102: 1S-M Military Kit 8mm
• 27290111503003: 1S-M Emergency Kit 8mm
• 27290111502204: 3S Hospital Pack 8mm
• 27290111502105: 3S Hospital Pack 6mm
• 27290111502006: 3S Hospital Pack 4mm
• 27290111501108: 1S-AD First-Aid Kit 8mm
• 27290111501009: 1S-AD First-Aid Kit 4mm
• 27290111500200: 1S Clinic Pack 8mm
• 27290111500002: 1S Clinic Pack 4mm
• 07290108159820: 1S-VET Veterinary Pack 8mm
• 07290108159523: 5S-VET Veterinary Pack 8mm
• 07290108154108: 3S-M Rescue Kit 8mm
• 27290108154003: 1S-M Rescue Kit 8mm