3.2mm Pre-Drill Sleeve 027-107

GUDID 00688346001372

Laboratoires Bodycad Inc

Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 00688346001372
• NIH Device Record Key: 614af647-615f-4eed-9ab3-e89a43a85ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.2mm Pre-Drill Sleeve
• Version Model Number: 027-107
• Catalog Number: 027-107
• Company DUNS: 202981171
• Company Name: Laboratoires Bodycad 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00688346001372 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

[00688346001372]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

Devices Manufactured by Laboratoires Bodycad Inc

• 00688346000047 - Fine Osteotomy system - Proximal tibia: 2024-02-19 Proximal tibia, plate, screws (compression cortical/cancellous), guides
• 00688346000078 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (compression cortical/cancellous), guides
• 00688346000108 - Fine Osteotomy implants - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical/cancellous compression)
• 00688346000122 - Fine Osteotomy implants - Proximal tibia: 2024-02-19 Proximal tibia, plate, screws (cortical/cancellous compression)
• 00688346000283 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical locking, cancellous compression), guides
• 00688346000290 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, cancellous screws compression, guides
• 00688346000320 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, cortical locking screws, guides
• 00688346000337 - Fine Osteotomy system - Distal femur: 2024-02-19 Distal femur, plate, screws (cortical locking, cortical compression), guides