RePlay 1170-01

GUDID 10816734021481

RePlay Hemostasis Clip, 11mm span

DIVERSATEK HEALTHCARE, INC.

Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 10816734021481
• NIH Device Record Key: d750cfec-2ec3-4c03-aa05-44d4db217385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RePlay
• Version Model Number: 1170-01
• Catalog Number: 1170-01
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Dimensions

• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter
• Width: 11 Millimeter

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734021484 [Primary]
GS1	10816734021481 [Package]; Contains: 00816734021484; Package: case [5 Units]; In Commercial Distribution

FDA Product Code

• PKL: Hemostatic Metal Clip For The Gi Tract

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-22
• Device Publish Date: 2018-08-01

On-Brand Devices [RePlay]

• 10816734021498: RePlay Hemostasis Clip, 16mm span
• 10816734021481: RePlay Hemostasis Clip, 11mm span