ORTHOCORD CHIA PERCPASSER

Basic Information

• Brand Name: ORTHOCORD CHIA PERCPASSER
• Primary DI: 10886705023349
• Version / Model: 232426
• Catalog Number: 232426
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 6
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: df797fc3-f463-4110-8629-0ed43290dd35

Device Description

TENODESIS DISPOSABLES KIT ORTHOCORD Suture, CHIA PERCPASSER Suture Passer and Instruments 1.6mm x 35cm (14 Inches) Guidewire, 1.1mm x 35cm (14 Inches) Guidewire, 1.1mm x 38cm (15 Inches) Nitinol Guidewire, 2.4mm x 38cm (15 Inches) Trocar Tip Calibrated Pin ( Percent accuracy = Plus or Minus 5 Percent), Size 2 (metric) ORTHOCORD Violet/Blue, 36 Inches (90cm) MO-6 Needle, CHIA PERCPASSER Suture Passer, Marking Pen, Ruler ( Percent accuracy = Plus or Minus 1 Percent).

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16584	Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886705023349	GS1

Customer Contacts

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