IMHS 71682514R

GUDID 03596010517494

IMHS CP 125 D 14MM X 19.5CM RIGHT

Smith & Nephew, Inc.

Arthrodesis nail

• Primary Device ID: 03596010517494
• NIH Device Record Key: 6a59c471-b05a-4893-a469-054a568d8689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMHS
• Version Model Number: 71682514R
• Catalog Number: 71682514R
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010517494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040656

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-08
• Device Publish Date: 2015-08-25

On-Brand Devices [IMHS]

• 00885556130865: IMHS CP 125 D 14MM X 34CM RIGHT
• 00885556040119: ASIAN IMHS GUIDE BOLT
• 00885556040041: 3.2MM ANTI-ROTATION SLEEVE
• 00885556039885: ASIAN IMHS 13MM X 19CM 130 D
• 00885556039854: ASIAN IMHS REDUCER
• 00885556039595: ASIAN IMHS 11MM X 19CM 130 D
• 00885556039410: ASIAN IMHS 25 DEG CANNULATED AWL
• 00885556039243: ASIAN IMHS 7 DEG CANNULATED AWL
• 00885556039229: ASIAN IMHS FLEXIBLE REAMER SHAFT
• 00885556039175: LAG SCREW INSERTER
• 00885556039014: ASIAN IMHS SUBTROCH DRILL
• 00885556039007: ASIAN IMHS 9 X 19 130 D
• 00885556038796: ASIAN IMHS 9MM X 16.5 CM 130 D
• 00885556038673: ASIAN IMHS LAG SCREW DRILL
• 00885556038338: ASIAN IMHS RETAINING HEX DRIVER
• 00885556038321: ASIAN IMHS ANTIROTATIONAL PIN GUIDE
• 00885556038314: ASIAN IMHS LAG SCREW LENGTH GAUGE
• 00885556038086: ASIAN IMHS LAG SCREW REMOVAL INST
• 00885556038079: LAG SCREW RETAINING ROD
• 00885556038000: ASIAN IMHS 13MM X 16.5 CM 130 D
• 00885556037898: ASIAN IMHS DRILL GUIDE 130 DEGREE
• 00885556037850: ASIAN IMHS 11MM X 19CM 125 D
• 00885556037843: ASIAN IMHS COMPRESSION DIAL
• 00885556037836: ASIAN IMHS 3.2MM TIP THREADED GUIDE PIN
• 00885556037737: ASIAN IMHS 9MM X 19CM 125 D
• 00885556037713: 2.4MM ANTI-ROTATION SLEEVE
• 00885556037676: ASIAN IMHS ENTRY REAMER
• 00885556037652: ASIAN IMHS 11MM X 16.5 CM 130 D
• 00885556037638: ASIAN IMHS 13MM X 16.5 CM 125 D
• 00885556037621: ASIAN IMHS 10MM X 30CM 130 D LEFT
• 00885556037591: ASIAN IMHS 11MM X 100-110MM SLIDING LAG W/SLEEVE
• 00885556037584: ASIAN IMHS 11MM X 16.5 CM 125 D
• 00885556037577: ASIAN IMHS 10MM X 28CM 130 D RIGHT
• 00885556037553: ASIAN IMHS 10MM X 28CM 130 D LEFT
• 00885556037522: ASIAN IMHS 9MM X 16.5CM 125 D
• 00885556037508: ASIAN IMHS 11MM X 90-100MM SLIDING LAG W/ SLEEVE
• 00885556037478: ASIAN IMHS NAIL CAP 0MM
• 00885556037454: ASIAN IMHS 10MM X 26CM 130 D RIGHT
• 00885556037423: ASIAN IMHS 10MM X 24CM 130 D RIGHT
• 00885556037393: ASIAN IMHS 11MMX85MM SUBTROCHANTERIC LAG SCREW
• 00885556037331: ASIAN IMHS 10MM X 32CM 130 D RIGHT
• 00885556037249: ASIAN IMHS 11MMX80MM SUBTROCHANTERIC LAG SCREW
• 00885556037195: ASIAN IMHS 10MM X 24CM 130 D LEFT
• 00885556037157: ASIAN IMHS 11MMX100MM SUBTROCHANTERIC LAG SCREW
• 00885556037133: ASIAN IMHS 11MM X 80-90MM SLIDING LAG W/ SLEEVE
• 00885556037119: ASIAN IMHS COMPRESSION SCREW REPLACEMENT
• 00885556037058: ASIAN IMHS 10MM X 32CM 130 D LEFT
• 00885556036914: ASIAN IMHS 10MM X 26CM 130 D LEFT
• 00885556036884: ASIAN IMHS SET SCREW
• 00885556036761: ASIAN IMHS 10MM X 30CM 130 D RIGHT