RePlay

Basic Information

• Brand Name: RePlay
• Primary DI: 00816734023174
• Version / Model: 1170-03
• Catalog Number: 1170-03
• Company Name: DIVERSATEK HEALTHCARE, INC.
• Labeler DUNS: 030650113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 1af725c7-5d17-4ccc-9a16-ae4addeff59a

Device Description

RePlay Hemostasis Clip, 18 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61207	Gastrointestinal endoscopic clip, short-term	A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816734023171	GS1	Inner Case	5	In Commercial Distribution
Primary	00816734023174	GS1
Package	20816734023178	GS1	Outer Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal