General Instrument 01-1003-6167

GUDID 00841132125540

Torque Limiter T-Handle, X-Link

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132125540
• NIH Device Record Key: 79a31e6a-ba21-445f-9d79-55f5840e9f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Instrument
• Version Model Number: 01-1003-6167
• Catalog Number: 01-1003-6167
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132125540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150600

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-25

On-Brand Devices [General Instrument]

• 00841132133194: ORTHOPEDIATRICS CASE COMPLETE MASTER LABEL WITH CE MARK
• 00841132133187: ORTHOPEDIATRICS LID, SMALL
• 00841132128701: 3.2mm Guide Tube
• 00841132128695: 4.5mm Guide Tube
• 00841132128688: Outer Guide Tube
• 00841132128671: Modular Drill Guide (Right)
• 00841132128664: Modular Drill Guide (Left)
• 00841132128657: Insertion Handle
• 00841132128640: Targeting Guide Attachment Bolt
• 00841132128633: 2.7mm X 810mm Guide Wire Ball Tip End
• 00841132128626: Exchange Tube
• 00841132128619: 2.0mm Smooth Guide Wire
• 00841132128602: Double Drill Guide 3.2/1.60mm
• 00841132128596: Rod Reducer, Gun Style
• 00841132128589: Feeler Probe, 200mm
• 00841132128572: Provisional Reduction Device Tension Sleeve
• 00841132128565: Extended Drill Guide Angle Arm
• 00841132128558: Extended Drill Guide Frame
• 00841132128541: Drill Guide Angle Arm
• 00841132128534: Guide Tube
• 00841132128527: Drill Guide Angle Arm, Elbow
• 00841132128510: Drill Guide Frame
• 00841132128503: Percutaneous Pinning Tray Lid
• 00841132128497: Percutaneous Pinning Tray 2
• 00841132128480: Percutaneous Pinning Tray 1
• 00841132128473: Extraction Adaptor
• 00841132128466: Slap Hammer Assembly
• 00841132128459: Impaction Rod
• 00841132128442: IM Reducer
• 00841132128435: Modular Targeting Device
• 00841132128428: Nail Inserter
• 00841132128411: T-Handle Wire Inserter
• 00841132128404: Depth Gauge 10-100mm
• 00841132128398: Mini QC Chuck with Zimmer Hudson End
• 00841132128381: Pusher
• 00841132128374: T-Handle Hex Driver for Targeting Device
• 00841132128367: 2lb Mallet
• 00841132128350: Inner Measuring Rod Assembly
• 00841132128343: 12mm Tissue Protector Sleeve
• 00841132128336: 10mm Tissue Protector Sleeve
• 00841132128329: Tissue Protector Small
• 00841132128312: 3.75mm Guide Tube
• 00841132128305: Short, Large Set Screw Driver
• 00841132128299: ASPIRE Orthopedic Spine Rod Cutter
• 00841132128282: ASPIRE Orthopedic Spine Implant Case
• 00841132128275: ASPIRE Orthopedic Spine Instrument Case 2
• 00841132128268: ASPIRE Orthopedic Spine Instrument Case 1
• 00841132128251: ASPIRE Spine Lid
• 00841132128244: Pedicle Depth Gauge Scale
• 00841132128237: Pedicle Depth Gauge Sleeve