ONETRAC

GUDID M648C1003002

ONETRAC Retractor MINNESOTA with Built-In Single-Use Light Source - STERILE

OBP CORPORATION

Hand-held surgical retractor, single-use

• Primary Device ID: M648C1003002
• NIH Device Record Key: b3b8205d-5a8c-4844-8b4f-ea1ae8786fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONETRAC
• Version Model Number: C100300
• Company DUNS: 011560431
• Company Name: OBP CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M648C1003000 [Primary]
HIBCC	M648C1003001 [Package]; Contains: M648C1003000; Package: BOX [5 Units]; In Commercial Distribution
HIBCC	M648C1003002 [Package]; Contains: M648C1003001; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• GAD: Retractor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-31
• Device Publish Date: 2019-10-23

On-Brand Devices [ONETRAC]

• M648C1003002: ONETRAC Retractor MINNESOTA with Built-In Single-Use Light Source - STERILE
• M648C1001702: ONETRAC Retractor 55mmx8mm with Built-In Single-Use Light Source - STERILE