Arthrex

GUDID 00615521004613

Denyer Clamp, Shoulder Suspension System

ALLEN MEDICAL SYSTEMS, INC.

Operating table traction frame

• Primary Device ID: 00615521004613
• NIH Device Record Key: 6bf1fce5-68c3-4a9e-944f-892f043793ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex
• Version Model Number: AR-1650-10
• Company DUNS: 147805894
• Company Name: ALLEN MEDICAL SYSTEMS, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com
• Phone: +1(800)934-4404
• Email: complaints@arthrex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615521004613 [Primary]

FDA Product Code

• FMP: Protector, skin pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

On-Brand Devices [Arthrex]

• 00615521039059: HDS, Table Clamp Set, DEN
• 00615521021849: HDS, Perineal Post Pad
• 00615521004880: HDS, Table Clamp Set, JP
• 00615521004866: HDS, Table Clamp Set, UK
• 00615521004842: Stabilizer Leg, HDS
• 00615521004835: HDS, Well Leg Adaptor
• 00615521004828: HDS Long Well Leg Spar
• 00615521004804: HDS Operative Spar Cover
• 00615521004781: HDS, Table Clamps, EU
• 00615521004774: HDS, Table Clamps, US
• 00615521004750: HDS, Perineal Post
• 00615521004736: HDS Long Operative Leg Spar
• 00615521004729: Prep Table Attachment, HDS
• 00615521004712: HDS, Patient Platform
• 00615521004699: TENSIOMETER
• 00615521004682: Sterilizable Clamp
• 00615521004675: Quick Release Post
• 00615521004668: Ankle Distractor
• 00615521004620: Japan Clamp, Shoulder Suspension System
• 00615521004613: Denyer Clamp, Shoulder Suspension System
• 00615521004606: UK Clamp, Shoulder Suspension System
• 00615521004590: EU Clamp, Shoulder Suspension System
• 00615521004583: US Clamp, Shoulder Suspension System
• 00615521004569: Weight, 2.5lb (1.1kg)
• 00615521004552: Weight Hanger, 10 lbs (4.5kg), S3
• 00615521004521: Shoulder Suspension Tower
• 00615521004514: Univ Head Positnr, w/out Hndls, Arthrex
• 00615521004507: Clamp for JP OR Bed Clark Rails
• 00615521004491: UHP Replace Strap, Beach Chair, Arthrex
• 00615521004460: Reusable Security Strap
• 00615521004439: Easy Lock Socket, EU
• 00615521004422: Easy Lock Socket US
• 00615521004415: Clamp for UK OR Bed Clark Rails
• 00615521004408: Clamp for EU OR Bed Clark Rails
• 00615521004392: Clamp for US OR Bed Clark Rails
• 00615521004385: Intubation Pad & Plate
• 00615521004354: Universal Head Positioner