MODULAR RAIL SYSTEM 71934027

GUDID 00885556066331

3.8MM/ 1.8MM LONG CANNULATED DRILL FOR HALF PINS

Smith & Nephew, Inc.

Cannulated surgical drill bit, single-use, sterile Cannulated surgical drill bit, single-use, sterile Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, single-use Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable

• Primary Device ID: 00885556066331
• NIH Device Record Key: c38d3725-40dd-4d5d-ae35-c443f7bca7a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODULAR RAIL SYSTEM
• Version Model Number: 71934027
• Catalog Number: 71934027
• 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: 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

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
• 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
• 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	00885556066331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093047

FDA Product Code

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

Sterilization

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

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

[00885556066331]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• 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