GUDID 00850005084716

Ø4.0mm Carbide Drill Bit 50mm OAL, Left Hand

PACIFIC INSTRUMENTS, INC.

Orthopaedic bur, reusable

• Primary Device ID: 00850005084716
• NIH Device Record Key: 444ff21b-9582-4ce1-a070-7a07e138e3dc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PI-2640
• 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	00850005084716 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

[00850005084716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-06
• Device Publish Date: 2024-07-29

Devices Manufactured by PACIFIC INSTRUMENTS, INC.

• 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
• 00850005084983 - NA: 2025-04-18 Bone Holding Forceps
• 00850005084990 - NA: 2025-04-18 Bone Reduction Forceps, Curved, Pointed Tips, 131mm OAL
• 00850005084938 - NA: 2024-12-26 Sure Grip 120, OAL 197mm, AO QC, Ratcheting, Cannulated
• 00850005084921 - NA: 2024-11-14 TBD
• 00850005084723 - NA: 2024-10-08 Ø4.0mm Carbide Drill Bit 75 mm OAL, Left Hand