ONETRAC

GUDID M648C1001702

ONETRAC Retractor 55mmx8mm with Built-In Single-Use Light Source - STERILE

OBP CORPORATION

Hand-held surgical retractor, single-use

• Primary Device ID: M648C1001702
• NIH Device Record Key: b569cb7c-d696-4c57-9672-29f0b4b6955e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONETRAC
• Version Model Number: C100170
• 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	M648C1001700 [Primary]
HIBCC	M648C1001701 [Package]; Contains: M648C1001700; Package: Box [5 Units]; In Commercial Distribution
HIBCC	M648C1001702 [Package]; Contains: M648C1001701; 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