GUDID 00810168190112

Distraction Screw, 14mm

PACIFIC INSTRUMENTS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810168190112
• NIH Device Record Key: 475ff3d0-9486-4843-a4b7-64f57d444409
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PI-1672
• Company DUNS: 621872006
• Company Name: PACIFIC INSTRUMENTS, 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	00810168190112 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

[00810168190112]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-30
• Device Publish Date: 2025-05-22

Devices Manufactured by PACIFIC INSTRUMENTS, INC.

• 00810168190136 - NA: 2025-07-18 Nonparallel Distractor for up to 6.0mm Rod
• 00810168190143 - NA: 2025-07-18 Nonparallel Compressor for up to 6.0mm Rod
• 00810168190075 - NA: 2025-07-03 5x8mm Cup Curette, Straight
• 00810168190099 - NA: 2025-07-03 5x8mm Cup Curette, Angled Up
• 00810168190129 - NA: 2025-07-03 Scalpel Handle, 8 Inch
• 00810168190112 - NA: 2025-05-30Distraction Screw, 14mm
• 00810168190112 - NA: 2025-05-30 Distraction Screw, 14mm
• 00850005084952 - NA: 2025-04-25 12 Inch Scalpel
• 00850005084969 - NA: 2025-04-25 6.0 Double Action Rod Gripper