Jet-X 71063008

GUDID 03596010486837

3.5MM DRILL SLEEVE

Smith & Nephew, Inc.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 03596010486837
• NIH Device Record Key: b783b2c0-020d-4ac9-a68b-a1a5f0a9021d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet-X
• Version Model Number: 71063008
• Catalog Number: 71063008
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010486837 [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

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

[03596010486837]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-25

On-Brand Devices [Jet-X]

• 00885556649633: JET-X 6MM X 60MM X 287MM
• 00885556618172: SS JET-X HALF PINS 6MM X 60MM X 287MM
• 00885556119808: JET-X TITANIUM 5MM X 50MM LONG HALF PIN
• 00885556119792: JET-X TITANIUM 5MM X 55MM LONG HALF PIN
• 00885556119785: JET-X TITANIUM 5MM X 60MM LONG HALF PIN
• 00885556119761: JET-X TITANIUM 5MM X 70MM LONG HALF PIN
• 00885556119747: JET-X LONG TITANIUM 6MMX20MM
• 00885556119730: JET-X LONG TITANIUM 6MMX25MM
• 00885556119723: JET-X LONG TITANIUM 6MMX30MM
• 00885556119716: JET-X LONG TITANIUM 6MMX35MM
• 00885556119709: JET-X LONG TITANIUM 6MMX40MM
• 00885556119693: JET-X LONG TITANIUM 6MMX45MM
• 20885556119659: JET-X 5MM X 35MM TIN EXTRA SHORT HALF PIN STERILE
• 20885556119642: JET-X 5MM X 45MM EXTRA SHORT HALF PIN STERILE
• 00885556119631: JET-X DRILL EXTRA SHORT 5MM HALF PIN STERILE
• 00885556119624: JET-X DRILL SHORT 5MM HALF PIN STERILE
• 00885556119617: JET-X DRILL LONG 5MM HALF PIN STERILE
• 00885556119600: JET-X DRILL SHORT 6MM HALF PIN STERILE
• 00885556119594: JET-X DRILL LONG 6MM HALF PIN STERILE
• 00885556065877: JETX 5MM X 40 SHORT HALF PIN
• 00885556064054: JETX 5MM X 40 LONG HALF PIN
• 00885556063927: JET-X 5.0MM HALF PIN 90MM THREADS X 255MM
• 00885556062913: 4.5MM T25 CORTEX SCREW 48MM S-T
• 00885556061640: 4.5MM T25 CORTEX SCREW 52MM S-T
• 00885556061381: 10IN EXTENDED JET-X V-BAR
• 00885556059531: 3.0MM X 40MM THREAD HALF PIN SHORT
• 00885556057520: 1.6MM X 330MM GUIDE WIRE
• 00885556056660: 5MM X 70MM X 250MM X 1.6MM CANNULATED HALF PIN
• 00885556056332: JET-X BAR 5MM X 400MM X 100MM THREAD HALF PIN
• 20885556055179: JETX HALF PIN 4MM X 25MM THREAD LENGTH
• 00885556054499: JET X 10.5MM X 750MM COMPOSITE BAR
• 20885556052994: JETX HALF PIN 4MM X 45MM THREAD LENGTH
• 00885556051665: 3.5MM SHORT DRILL W/A/O CONNECTOR
• 00885556013687: JETX DRILL SLEEVE W/TROCAR F/5 & 6MM SHORT HP
• 20885556013667: JET-X 5MM X 30MM TIN LONG HALF PIN STERILE
• 20885556013544: JET-X 5MM X 55MM TITANIUM NITRIDE LONG HALF PIN STERILE
• 20885556013490: JET-X 5MM X 50MM TIN SHORT TRACTION PIN STERILE
• 00885556013458: JETX 4.8MM GRAD STEP DRILL F/ 6MM SHORT HP
• 20885556013315: JET-X 4MM X 35MM TIN HALF PIN STERILE
• 20885556013292: JET-X 5MM X 70MM TIN SHORT HALF PIN STERILE
• 00885556013267: JET-X TP/ DS COMBO FOR 6MM HALF PINS
• 20885556013186: JET-X 6MM X 55MM TITANIUM NITRIDE HALF PIN STERILE
• 00885556013168: JETX ADD A BAR COUPLER
• 20885556013148: JET-X 5MM X 30MM TITANIUM NITRIDE SHORT HALF PIN STERILE
• 20885556013124: JET-X 5MM X 55MM TIN SHORT HALF PIN STERILE
• 20885556013087: JET-X 5MM X 40MM TIN EXTRA SHORT HALF PIN STERILE
• 20885556013032: JET-X 5MM X 45MM TITANIUM NITRIDE LONG HALF PIN STERILE
• 20885556013018: JET-X 5MM X 30MM TITANIUM NITRIDE EXTRA SHORT HALF PIN STERI
• 20885556013001: JET-X 3MM X 15MM TITANIUM NITRIDE HALF PIN STERILE
• 00885556012994: JETX 5X40MM TiN CANN HALF PIN W/1.6MM GUIDE WIRE