DEKNATEL

Basic Information

• Brand Name: DEKNATEL
• Primary DI: 14026704724946
• Version / Model: IPN914512
• Catalog Number: E13-6338
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-11
• Public Version: 2
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 02dfda91-39fa-4739-a376-a253b429d66e

Device Description

POLYLENE GREEN 3-0 DS18 1N 45 CENTIMETER

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 Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31744	Cardiovascular patch, synthetic	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704724943	GS1	Box	36	In Commercial Distribution
Primary	14026704724946	GS1
Previous	14026704637437	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			POLYLENE /Needle DS18 Size-3-0
Length	45	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: none