Orthopedic manual surgical instrument

GUDID 04719883337269

10mm Trial

BAUI BIOTECH CO. LTD.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 04719883337269
• NIH Device Record Key: 64c23c17-ab69-42f4-b8f0-7dd5c37aa4e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopedic manual surgical instrument
• Version Model Number: 420-0410C
• Company DUNS: 656775504
• Company Name: BAUI BIOTECH CO. LTD.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719883337269 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

[04719883337269]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-22
• Device Publish Date: 2025-01-14

On-Brand Devices [Orthopedic manual surgical instrument]

• 04719883854803: Cup Curette, angled, right
• 04719883854797: Cup Curette, angled, left
• 04719883337306: 14mm Trial
• 04719883337290: 13mm Trial
• 04719883337283: 12mm Trial
• 04719883337276: 11mm Trial
• 04719883337269: 10mm Trial
• 04719883337252: 9mm Trial
• 04719883337245: 8mm Trial
• 04719883337238: 7mm Trial
• 04719883337221: 14mm Shaver
• 04719883337214: 12mm Shaver
• 04719883337207: 10mm Shaver
• 04719883337191: 8mm Shaver
• 04719883337177: Cage Remover
• 04718005159888: Cage Pusher
• 04718005159871: Comet Lumbar Implant Driver
• 04718005159864: 8mm Osteotome
• 04718005159857: Rasp, dual-sided, angled
• 04718005159840: Rasp, dual-sided, straight
• 04718005159833: Cup Curette
• 04718005159826: Curette, rectangular, angled, right
• 04718005159819: Curette, rectangular, angled, left
• 04718005159802: Curette, rectangular
• 04718005159789: 13mm Shaver
• 04718005159772: 11mm Shaver
• 04718005159765: 9mm Shaver
• 04718005159758: 7mm Shaver
• 04718005159710: Bone Graft Impactor
• 04718005159703: Slap Hammer
• 04718005159697: Bone Tamper
• 04718005159680: Bone Funnel
• 04718005155156: T-Handle
• 04710577045989: Lumbar Bone Graft Template
• 04719883858610: 5mm Hex Screw Driver(initial tightening)
• 04719883855428: 6mm Tap
• 04719883855411: 5mm Tap
• 04719883337429: 5mm Hex Simple Screw Driver(double-sided)
• 04719883337399: 5mm Hex Set Screw Holder
• 04719883337382: Rod Holder
• 04719883337320: 5.5mmTap (Cannulated)
• 04719883337313: 4.5mm Tap (Cannulated)
• 04719883333063: Rachet Handle
• 04718005155484: Torque Wrench 3N-m
• 04718005155330: Caliper
• 04718005155309: Rod Gripper
• 04718005155262: Gun-type Pull-up Pliers
• 04718005155255: 5mm Rotator Bar
• 04718005155248: Rod Pusher
• 04718005155231: 3mm Hex Screw Driver