HOFFMANN 5028-8-065

GUDID 04546540495136

Connecting Rod

Stryker Trauma SA

External orthopaedic fixation system, reusable

• Primary Device ID: 04546540495136
• NIH Device Record Key: 852c1829-0678-4271-8a6b-4897f5c42533
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOFFMANN
• Version Model Number: 5028-8-065
• Catalog Number: 5028-8-065
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540495136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053472

FDA Product Code

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

Sterilization

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

[04546540495136]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [HOFFMANN]

• 07613327297751: LRF Web Application
• 07613327294286: LRF Hexapod Strut - Short - Length 105-139mm
• 07613327294279: LRF Hexapod Strut ID Kit
• 07613327294262: LRF Hexapod Strut Insert
• 07613327294255: LRF Hexapod Strut - Extra Short - Length 89-109mm
• 07613327294248: LRF Hexapod Strut Change-Out Caddy
• 07613327294231: LRF Hexapod Strut - Medium - Length 131-191mm
• 07613327294224: LRF Hexapod Generic Full Insert
• 07613327294217: LRF Hexapod Tray
• 07613327294200: LRF Hexapod Strut - Long - Length 183-295mm
• 07613327294194: LRF Hexapod Generic Half Insert with Lid
• 07613327261042: Bone Transport Strut End Cap HLRF
• 07613327142839: Bone Transport Tray HLRF
• 07613327131475: Safety Clip (Bone Transport Strut) HLRF
• 07613327129809: Lengthening Ruler HLRF
• 07613327096293: Trocar
• 07613327096286: Tissue Protection Sleeve ¿5mm
• 07613327096224: Tray Gradual Correction LRF
• 07613327095104: Universal Hinge Strut - Extra Short LRF
• 07613327095098: Universal Joint LRF
• 07613327095067: Universal Foot Support
• 07613327094978: Tube to Rod Coupling 20mm / 8mm
• 07613327094664: Tray Select Rings
• 07613327094640: Transport Strut HLRF
• 07613327093315: Sterile Wrist Kit
• 07613327093292: Sterile Tibial Kit
• 07613327093261: Sterile Ankle Kit
• 07613327092677: Stainless Steel Straight Post Compact
• 07613327092660: Stainless Steel Straight Post
• 07613327092653: Angled Post, Stainless Steel
• 07613327092646: Stainless Steel Angled Post Compact
• 07613327092639: Stainless Steel Angled Post
• 07613327092608: Stabilisation / Reduction Wrench
• 07613327092592: Stabilisation / Reduction Wrench
• 07613327092530: Spherical Washer LRF
• 07613327092318: Slotted Plate LRF 10 x 60mm
• 07613327092103: Semi-Circular Curved Rod Compact
• 07613327092080: Semi-Circular Curved Rod Compact
• 07613327092035: Semi-Circular Curved Rod
• 07613327092028: Self-Locking Nut LRF Thread M6
• 07613327091540: Rod To Rod Coupling Micro 5/3mm
• 07613327091533: Rod To Rod Coupling Micro 3/3mm
• 07613327091526: Rod To Rod Coupling Compact 8/5mm
• 07613327091519: Rod To Rod Coupling Compact 5/5mm
• 07613327091502: Rod Coupler; 30¿
• 07613327091496: Rod To Rod Coupling 8/8mm
• 07613327091441: Removable Thumbwheel 7/5mm
• 07613327089172: Pin to Rod Coupling, multiplanar ¿4/5/6mm, ¿5/8/11mm
• 07613327089165: Pin To Rod Coupling Micro 1,65-2/3mm
• 07613327089158: Pin To Rod Coupling Compact 5/3-4mm