MODULAR RAIL SYSTEM 71934018

GUDID 00885556066478

4.8MM LONG DRILL SLEEVE

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00885556066478
• NIH Device Record Key: d36c2ad0-55dc-4d53-9cbd-39a6dc4692d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODULAR RAIL SYSTEM
• Version Model Number: 71934018
• Catalog Number: 71934018
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556066478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

Moist Heat or Steam Sterilization

[00885556066478]

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: 2015-08-29

On-Brand Devices [MODULAR RAIL SYSTEM]

• 00885556614662: RAIL DISTRACTOR LOW PROFILE LEFT
• 00885556337196: RAIL SCREW CADDY
• 00885556337097: RAIL INSTRUMENT TRAY LID
• 00885556337042: LARGE RAIL HIP TRAY LID
• 00885556336991: SMALL RAIL HIP TRAY LID
• 00885556336946: LARGE RAIL TRAY LID
• 00885556336892: SMALL RAIL TRAY LID
• 00885556322741: RAIL INSTRUMENT TRAY
• 00885556322697: LARGE RAIL HIP TRAY
• 00885556322642: LARGE RAIL TRAY
• 00885556322598: SMALL RAIL HIP TRAY
• 00885556322543: SMALL RAIL TRAY
• 00885556319741: SMALL RAIL 339MM
• 00885556319697: SMALL RAIL 226MM
• 00885556319642: RAIL 339MM
• 00885556319598: RAIL 226MM
• 00885556318393: SMALL RAIL ARC SHORT ASSY
• 00885556274613: SMALL RAIL ANTERIOR POSTERIOR POST
• 00885556274569: SMALL RAIL MEDIAL LATERAL POST
• 00885556274514: RAIL ANTERIOR POSTERIOR POST
• 00885556274460: RAIL MEDIAL LATERAL POST
• 00885556251799: RAIL DISTRACTOR LOW PROFILE LEFT
• 00885556251744: RAIL DISTRACTOR LOW PROFILE RIGHT
• 00885556235997: SMALL COLLAPSE LIMITER
• 00885556235942: COLLAPSE LIMITER
• 00885556235898: SMALL SWIVEL CLAMP
• 00885556235843: SWIVEL CLAMP
• 00885556235706: T20 SHORT DRIVER
• 00885556235652: RAIL ARC SHORT - NON THREADED
• 00885556235607: RAIL SHORT
• 00885556235553: RAIL LOCK 100MM
• 00885556235508: RAIL LOCK 90MM
• 00885556235454: RAIL LOCK 80MM
• 00885556235409: RAIL LOCK 70MM
• 00885556235355: RAIL LOCK 60MM
• 00885556235300: RAIL LOCK 50MM
• 00885556224991: SMALL RAIL OFFSET MALE HINGE
• 00885556224946: RAIL OFFSET MALE HINGE
• 00885556224847: SMALL RAIL ARC 180 / 180MM - NON THREADED
• 00885556224793: RAIL ARC 180 / 205MM - NON THREADED
• 00885556224748: SMALL RAIL ARC SHORT - NON THREADED
• 00885556224694: SMALL RAIL ARC - NON THREADED
• 00885556224649: SMALL RAIL TO ARC CONNECTION - THREADED
• 00885556224595: RAIL ARC - NON THREADED
• 00885556224540: RAIL TO ARC CONNECTION - THREADED
• 00885556224496: SMALL RAIL OVER HANG CLAMP
• 00885556224441: RAIL OVER HANG CLAMP
• 00885556143483: T20 SCREWDRIVER SHAFT 178MM
• 00885556143339: RAIL KNEE HINGE ASSY
• 00885556143322: SMALL RAIL KNEE HINGE ASSY