ONETRAC

Basic Information

• Brand Name: ONETRAC
• Primary DI: M648C1001500
• Version / Model: C100150
• Catalog Number: C100150
• Company Name: OBP CORPORATION
• Labeler DUNS: 011560431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b50a6897-551d-4441-aa07-1392438d1492

Device Description

C100150 ONETRAC Retractor 40x20mm with Built-In Single-Use Light Source - STERILE

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13375	Abdominal retractor, hand-held	A surgical instrument designed to be held by the surgeon or assistant to separate the margins of an abdominal incision, typically during deep surgery, to expose or access organs or tissues for examination or intervention. The instrument consists of a blunt-edged, non-adjustable flat blade that curves near the distal tip, with a solid handle at the proximal end. The surgeon or assistant uses this instrument to manually pull the edge of the incision open. It is made of high-grade stainless steel and is available in a variety of blade lengths. This is a reusable device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M648C1001502	HIBCC	CASE	4	In Commercial Distribution
Package	M648C1001501	HIBCC	BOX	10	In Commercial Distribution
Primary	M648C1001500	HIBCC

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 45 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius