SOFTSILK 7207257

GUDID 03596010375537

SCR SFTSLK 2.0 PKG.7X25 STER

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03596010375537
• NIH Device Record Key: 118b33f6-6e29-4924-bee2-bfbfc8edd3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTSILK
• Version Model Number: 7207257
• Catalog Number: 7207257
• 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)821-5700
• 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	03596010375537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921481

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: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [SOFTSILK]

• 00885556608609: MTO SFTSLK SCRW 9MMX30MM STRL
• 00885556608593: MTO SFTSLK SCRW 9MMX25MM STRL
• 00885556608586: MTO SFTSLK SCRW 9MMX20MM STRL
• 00885556608579: MTO SFTSLK SCRW 8MMX30MM STRL
• 00885556608562: MTO SFTSLK SCRW 8MMX25MM STRL
• 00885556608555: MTO SFTSLK SCRW 8MMX20MM STRL
• 00885556608548: MTO SFTSLK SCRW 7MMX30MM STRL
• 00885556608531: MTO SFTSLK SCRW 7MMX25MM STRL
• 00885556608524: MTO SFTSLK SCRW 7MMX20MM STRL
• 00885554020786: MTO SCREW SOFTSILK 1.5 10 X 17 STERILE
• 00885554016826: MTO SCREW SOFTSILK 1.5 10 X 20 STERILE
• 00885554012736: MTO SOFTSILK SCRW STRL BX OF 1 12MMX25MM
• 00885554012408: MTO SFTSLK SCRW STRL BX OF 1 11MMX30MM
• 00885554012385: MTO SOFTSILK SCREW 13MMX40MM STRL BX OF1
• 00885554012194: MTO SOFTSILK SCRW STRL BX OF 1 12MMX40MM
• 00885554011975: MTO SOFTSILK SCREW 13MMX35MM STRL BX OF1
• 00885554011937: MTO SFTSLKSCRW STRL BX OF 1 11MMX25MM
• 00885554011463: MTO SOFTSILK SCREW 13MMX30MM STRL BX OF1
• 00885554011432: MTO SOFTSILK SCRW STRL BX 1 12MMX35MM
• 00885554011128: MTO SOFTSILK SCRW STRL BX OF 1 12MMX30MM
• 00885554011111: MTO SOFTSILK SCREW 13MMX25MM STRL BX OF1
• 03596010651501: MTO SOFTSILK SCRW STRL BX OF 1 10MMX30MM
• 03596010601476: MTO SOFTSILK SCRW STRL BX OF 1 10MMX25MM
• 03596010479433: SCR SOFTSLK NON-CAN 7X25 STER
• 03596010446091: SCR SOFTSLK NON-CAN 9X25 STER
• 03596010375544: SCR SFTSLK 2.0 PKG.7X30 STER
• 03596010375537: SCR SFTSLK 2.0 PKG.7X25 STER
• 03596010375445: SCR SFTSLK 2.0 PKG.9X30 STER
• 03596010252661: SCR SOFTSLK 1.5 8X25 STER
• 03596010252708: SCR SOFTSILK 1.5 9X30 STERILE
• 03596010252692: SCR SOFTSILK 1.5 9X25 STERILE
• 03596010252685: SCR SOFTSILK 1.5 9X20 STERILE
• 03596010252678: SCR SOFTSILK 1.5 8X30 STERILE
• 03596010252654: SCR SOFTSILK 1.5 8X20 STERILE
• 03596010252647: SCR SOFTSILK 1.5 7X30 STERILE
• 03596010252630: SCR SOFTSILK 1.5 7X25 STERILE
• 03596010252623: SCR SOFTSILK 1.5 7X20 STERILE
• 03596010375438: 9 X 25 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010375421: 9 X 20 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010375414: 8 X 30 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010375407: 8 X 25 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010375391: 8 X 20 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010375384: 7 X 20 MM SOFTSILK 2.0 SCREW, STERILE
• 03596010416988: CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED
• 03596010416971: CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED