PERCUVANCE

Basic Information

• Brand Name: PERCUVANCE
• Primary DI: 14026704640130
• Version / Model: IPN029174
• Catalog Number: PCVHCA5
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-22
• Public Version: 6
• Public Version Date: 2021-06-16
• Public Version Status: Update
• Public Device Record Key: 791c32f7-aad5-44e7-ab06-c5712dbc332a
• Distribution End Date: 2021-06-15

Device Description

HEM-O-LOK CLIP APPLIER

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35798	Open-surgery ligation clip applier	A hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	44026704640131	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Package	34026704640134	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Primary	14026704640130	GS1
Previous	14026704582805	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181852	000

Device Sizes

Type	Value	Unit	Text
Width	0.22	Inch
Length	2.8	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 16 – 37 Degrees Celsius