SMALL CANNULATED SCREWS 71102282S

GUDID 03596010623409

2.0MM QFX SCREW 12MM STERILE

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03596010623409
• NIH Device Record Key: c33a5b4c-f1e6-4ccc-bcf1-ebf29e2844e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMALL CANNULATED SCREWS
• Version Model Number: 71102282S
• Catalog Number: 71102282S
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: true
• 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
• 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	03596010623409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090675

FDA Product Code

• HRS: PLATE, 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: 2023-03-31
• Device Publish Date: 2015-08-30

On-Brand Devices [SMALL CANNULATED SCREWS]

• 00885556701799: 2.2MM QFX SCREW 18MM STERILE
• 00885556701782: 2.2MM QFX SCREW 16MM STERILE
• 00885556701775: 2.2MM QFX SCREW 14MM STERILE
• 00885556701768: 2.2MM QFX SCREW 12MM STERILE
• 00885556701751: 2.2MM QFX SCREW 10MM STERILE
• 00885556701744: 2.2MM QFX SCREW 8MM STERILE
• 00885556118047: 5.5MM CANNULATED SCREW IMPLANT TRAY FOR TI SCREWS
• 00885556016619: 1.3MM X 2.7MM DRILL GUIDE
• 00885556014721: 5.5MM X 95MM CANNULATED SCREW FULL THREAD S.S
• 00885556014387: 5.5MM X 85MM CANNULATED SCREW FULL THREAD S.S
• 00885556014196: 5.5MM X 75MM CANNULATED SCREW FULL THREAD S.S
• 00885556014066: 5.5MM X 65MM CANNULATED SCREW FULL THREAD S.S
• 20885556013674: 3.0MM HEADLESS CANNULATED SCREW 23MM MULTI-PACK
• 20885556013476: 3.0MM CANNULATED SCREW 21MM MULTI-PACK
• 20885556013322: 3.0MM HEADLESS CANNULATED SCREW 30MM MULTI-PACK
• 20885556013131: 2.5MM CANNULATED SCREW 9MM MULTI-PACK
• 20885556013094: 3.0MM CANNULATED SCREW 20MM MULTI-PACK
• 20885556013063: 3.0MM HEADLESS CANNULATED SCREW 29MM MULTI-PACK
• 20885556012837: 3.0MM HEADLESS CANNULATED SCREW 28MM MULTI-PACK
• 20885556012752: 3.0MM HEADLESS CANNULATED SCREW 27MM MULTI-PACK
• 20885556012660: 3.0MM CANNULATED SCREW 19MM MULTI-PACK
• 20885556012462: 3.0MM HEADLESS CANNULATED SCREW 25MM MULTI-PACK
• 20885556012455: 3.0MM HEADLESS CANNULATED SCREW 40MM MULTI-PACK
• 03596010624154: 3.3MM X 4.0MM DRILL GUIDE
• 03596010624123: 0.9MM/1.1MM X 1.8MM/2.0MM DRILL GUIDE
• 03596010624093: 2.5MM/3.0MM CANNULATED DIRECT MEASURING DEVICE W/ COUNTERSIN
• 03596010630506: SMALL CANNULATED SCREW SYSTEM LID
• 03596010624239: SMALL CANNULATED SCREW INSTRUMENT TRAY
• 03596010624222: 3.0MM HEADLESS/2.0MM QFX SCREW CADDY DROP-IN
• 03596010624215: 2.5MM/3.0MM CANNULATED SCREW CADDY DROP-IN
• 03596010624208: SMALL CANNULATED SCREW SYSTEM TRAY
• 03596010624192: SMALL CANNULATED SCREW CADDY LID
• 03596010624185: SMALL CANNULATED SCREW CADDY
• 03596010624048: SMALL CANNULATED SCREW INSTRUMENT INNER TRAY
• 03596010624031: SMALL CANNULATED SCREW INSTRUMENT TRAY LID
• 03596010624307: 2.0MM CANNULATED DRILL BIT WITH QUICK CONNECT
• 03596010624291: 1.8MM CANNULATED DRILL BIT WITH QUICK CONNECT
• 03596010624178: CANNULATED T10 SCREWDRIVER HANDLE SHAFT WITH AO
• 03596010624130: 2.5MM/3.0MM COUNTERSINK WITH QUICK CONNECT
• 03596010624116: 2.5MM/3.0MM OBTURATOR
• 03596010624109: 2.5MM/3.0MM CLEANING BRUSH
• 03596010624086: SMALL CANNULATED HANDLE W/QC
• 03596010624017: 3.0MM CANNULATED SCREW 50MM STERILE
• 03596010624000: 3.0MM CANNULATED SCREW 45MM STERILE
• 03596010623997: 3.0MM CANNULATED SCREW 40MM STERILE
• 03596010623980: 3.0MM CANNULATED SCREW 38MM STERILE
• 03596010623973: 3.0MM CANNULATED SCREW 36MM STERILE
• 03596010623966: 3.0MM CANNULATED SCREW 34MM STERILE
• 03596010623959: 3.0MM CANNULATED SCREW 32MM STERILE
• 03596010623942: 3.0MM CANNULATED SCREW 30MM STERILE