Key Surgical Hemostasis Clips

Basic Information

• Brand Name: Key Surgical Hemostasis Clips
• Primary DI: 00849771039181
• Version / Model: EN10400A
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-03
• Public Version: 5
• Public Version Date: 2022-06-14
• Public Version Status: Update
• Public Device Record Key: fc2ec855-76af-4971-b714-62447cf5ee99
• Distribution End Date: 2022-06-14

Device Description

Hemostasis Clip, Rotatable, Single-Use, Coated, 11mm (Opening) W

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: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	10849771039195	GS1	Case	10	Not in Commercial Distribution	2022-06-08
Package	00849771039198	GS1	Box	5	Not in Commercial Distribution	2022-06-08
Primary	00849771039181	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172727	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Opening span 11mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity