Orthex Tool RB-280B

GUDID 00841132180587

X-Ray Ball Bridge, 280mm

ORTHOPEDIATRICS CORP.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00841132180587
• NIH Device Record Key: 6f6a3895-e38f-4168-9c28-f0f84b1de572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Tool
• Version Model Number: RB-280B
• Catalog Number: RB-280B
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: bsmith@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132180587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

[00841132180587]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [Orthex Tool]

• 00841132180587: X-Ray Ball Bridge, 280mm
• 00841132180570: X-Ray Ball Bridge, 255mm
• 00841132180563: X-Ray Ball Bridge, 230mm
• 00841132180556: X-Ray Ball Bridge, 205mm
• 00841132180549: X-Ray Ball Bridge, 180mm
• 00841132180532: X-Ray Ball Bridge, 155mm
• 00841132180525: X-Ray Ball Bridge, 130mm
• 00841132180518: X-Ray Ball Bridge, 105mm
• 00841132179192: Half Pin Removal Tool, Adult
• 00841132179185: Half Pin Removal Tool, Ped
• 00841132177877: X-Ray Ball Bridge, Small Bone 130mm
• 00841132177860: X-Ray Ball Bridge, Small Bone 110mm
• 00841132177853: X-Ray Ball Bridge, Small Bone 95mm
• 00841132177846: X-Ray Ball Bridge, Small Bone 75mm
• 00841132177839: X-Ray Ball Bridge, Small Bone 60mm
• 00841132180648: 2.0MM DIA. NEUTRAL & LOAD END GREEN/GOLD DRILL GUIDE
• 00841132179949: Drill Sleeve, SB 5.0x4.5x100mm
• 00841132179888: Wire Sleeve, SB 4.5x1.5x110mm
• 00841132179871: 4.8 drill sleeve, Short
• 00841132179864: 4.8 drill sleeve, Long
• 00841132179789: Wire Sleeve 4.5x1.8x110mm
• 00841132178102: Orthex, Handle, AO Pull Adpt