ONETRAC LX

Basic Information

• Brand Name: ONETRAC LX
• Primary DI: M648C1002100
• Version / Model: C100210
• Company Name: OBP CORPORATION
• Labeler DUNS: 011560431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 1
• Public Version Date: 2019-10-31
• Public Version Status: New
• Public Device Record Key: 717c5571-387c-4695-98b6-a67703bda0c4

Device Description

Retractor 135x30mm with Built-In Single-Use Multi-LED 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
62562	Hand-held surgical retractor, single-use	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M648C1002102	HIBCC	CASE	10	In Commercial Distribution
Package	M648C1002101	HIBCC	BOX	1	In Commercial Distribution
Primary	M648C1002100	HIBCC