ProChondrix® Instrument Set

GUDID 00812337021210

Single-use disposable orthopedic manual surgical instrument set

DSM BIOMEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00812337021210
• NIH Device Record Key: 0c9cb3de-a75e-4a83-92f8-2ea4c86554e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProChondrix® Instrument Set
• Version Model Number: 58160-09
• Company DUNS: 131107757
• Company Name: DSM BIOMEDICAL, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter
• Outer Diameter: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812337021210 [Primary]

FDA Product Code

• HWK: Trephine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-13
• Device Publish Date: 2017-09-06

On-Brand Devices [ProChondrix® Instrument Set]

• 00812337021265: Single-use disposable orthopedic manual surgical instrument set
• 00812337021258: Single-use disposable orthopedic manual surgical instrument set
• 00812337021241: Single-use disposable orthopedic manual surgical instrument set
• 00812337021234: Single-use disposable orthopedic manual surgical instrument set
• 00812337021227: Single-use disposable orthopedic manual surgical instrument set
• 00812337021210: Single-use disposable orthopedic manual surgical instrument set
• 00812337021203: Single-use disposable orthopedic manual surgical instrument sets
• 00081233702126: Single-use disposable orthopedic manual surgical instrument set
• 00081233702125: Single-use disposable orthopedic manual surgical instrument set
• 00081233702124: Single-use disposable orthopedic manual surgical instrument set
• 00081233702123: Single-use disposable orthopedic manual surgical instrument set
• 00081233702122: Single-use disposable orthopedic manual surgical instrument set
• 00081233702121: Single-use disposable orthopedic manual surgical instrument set
• 00081233702120: Single-use disposable orthopedic manual surgical instrument sets