SMF 71360082

GUDID 03596010619266

PLASTIC TRIAL NECK STANDARD OFFSET

Smith & Nephew, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 03596010619266
• NIH Device Record Key: e736322d-953c-4b31-a8f9-8c4b6db1d23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMF
• Version Model Number: 71360082
• Catalog Number: 71360082
• 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	03596010619266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113789

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

[03596010619266]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-28

On-Brand Devices [SMF]

• 00885556280720: SMF STEM BROACH TRIAL NECK HIGH OFFSET VALGUS
• 00885556280713: SMF STEM BROACH TRIAL NECK LEFT ANTEVERTED VALGUS
• 00885556280706: SMF STEM BROACH TRIAL NECK RIGHT ANTEVERTED VALGUS
• 00885556280690: SMF STEM PUNCH
• 00885556280683: SMF STEM BROACH SZ -1
• 00885556280676: SMF STEM BROACH SIZE 0
• 00885556086995: SMF BROACH SIZE 1
• 03596010619358: SMF STEM INSERTER/EXTRACTOR SCREW
• 03596010619341: SMF STEM INSERTER/EXTRACTOR TAPER PLUG
• 03596010619334: SMF STEM INSERTER/EXTRACTOR
• 00885556769331: SMF BROACH SIZE 7 - SHARPER TEETH
• 00885556769324: SMF BROACH SIZE 6 - SHARPER TEETH
• 00885556769317: SMF BROACH SIZE 5 - SHARPER TEETH
• 00885556769300: SMF BROACH SIZE 4 - SHARPER TEETH
• 00885556769294: SMF BROACH SIZE 3 - SHARPER TEETH
• 00885556769287: SMF BROACH SIZE 2 - SHARPER TEETH
• 00885556772089: SMF BROACH SIZE 9 - SHARPER TEETH
• 00885556772072: SMF BROACH SIZE 8 - SHARPER TEETH
• 00885556772065: SMF BROACH SIZE 7 - SHARPER TEETH
• 00885556772058: SMF BROACH SIZE 6 - SHARPER TEETH
• 00885556772041: SMF BROACH SIZE 5 - SHARPER TEETH
• 00885556772034: SMF BROACH SIZE 4 - SHARPER TEETH
• 00885556772027: SMF BROACH SIZE 3 - SHARPER TEETH
• 00885556772010: SMF BROACH SIZE 2 - SHARPER TEETH
• 03596010655493: SMF INSTRUMENT TRAY 2
• 03596010655486: SMF INSTRUMENT TRAY 1
• 03596010619488: SMF STEM BROACH TRIAL NECK HIGH OFFSET
• 03596010619471: SMF STEM BROACH TRIAL NECK STANDARD OFFSET
• 03596010619464: SMF STEM BROACH SIZE 9
• 03596010619457: SMF STEM BROACH SIZE 8
• 03596010619440: SMF STEM BROACH SIZE 7
• 03596010619433: SMF STEM BROACH SIZE 6
• 03596010619426: SMF STEM BROACH SIZE 5
• 03596010619419: SMF STEM BROACH SIZE 4
• 03596010619402: SMF STEM BROACH SIZE 3
• 03596010619396: SMF STEM BROACH SIZE 2
• 03596010619297: PLASTIC TRIAL NECK RIGHT ANTEVERTED
• 03596010619280: PLASTIC TRIAL NECK LEFT ANTEVERTED
• 03596010619273: PLASTIC TRIAL NECK HIGH OFFSET
• 03596010619266: PLASTIC TRIAL NECK STANDARD OFFSET
• 00885556795231: SMF BROACH SIZE 7 - SHARPER TEETH
• 00885556795224: SMF BROACH SIZE 6 - SHARPER TEETH
• 00885556795217: SMF BROACH SIZE 5 - SHARPER TEETH
• 00885556795194: SMF BROACH SIZE 3 - SHARPER TEETH
• 00885556795187: SMF BROACH SIZE 2 - SHARPER TEETH
• 03596010619501: SMF STEM BROACH TRIAL NECK RIGHT ANTEVERTED
• 03596010619495: SMF STEM BROACH TRIAL NECK LEFT ANTEVERTED
• 03596010619303: SMF STEM OSTEOTOMY GUIDE