PERCUVANCE

Basic Information

• Brand Name: PERCUVANCE
• Primary DI: 14026704582898
• Version / Model: IPN027878
• Catalog Number: PCVSB5
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-16
• Public Version: 9
• Public Version Date: 2021-06-16
• Public Version Status: Update
• Public Device Record Key: f5cb95d7-88bf-4b62-8365-b3229ee3fa2b

Device Description

5MM SEAL BRIDGE

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
45597	Laparoscopic access cannula seal reducer	A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34026704582892	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Package	24026704582895	GS1	Box	6	Not in Commercial Distribution	2021-06-15
Primary	14026704582898	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153063	000

Device Sizes

Type	Value	Unit	Text
Width	0.7	Inch
Length	3.4	Inch

Storage Conditions

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