PERCUVANCE

Basic Information

• Brand Name: PERCUVANCE
• Primary DI: 14026704640178
• Version / Model: IPN029178
• Catalog Number: PCVMD5
• 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: 5
• Public Version Date: 2021-06-16
• Public Version Status: Update
• Public Device Record Key: 2a439a95-4dce-4d23-8a6b-578e2595da3e
• Distribution End Date: 2021-06-15

Device Description

MARYLAND DISSECTOR

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
47415	Laparoscopic blunt dissector	A sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34026704640172	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Primary	14026704640178	GS1
Package	44026704640179	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Previous	14026704582850	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181852	000

Device Sizes

Type	Value	Unit	Text
Length	3.1	Inch
Width	0.22	Inch

Storage Conditions

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