TC-100 71176535

GUDID 03596010432773

3.5MM DRILL BIT 95/80MM NON-QUICK COUPLING STER

Smith & Nephew, Inc.

Fluted surgical drill bit, single-use

• Primary Device ID: 03596010432773
• NIH Device Record Key: bda28b96-bc18-428a-9768-e86c76dff061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-100
• Version Model Number: 71176535
• Catalog Number: 71176535
• 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
• 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	03596010432773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

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: 5
• Public Version Date: 2020-07-23
• Device Publish Date: 2015-08-25

On-Brand Devices [TC-100]

• 00885556728826: SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
• 00885556728734: CANNULATED DEPTH GAUGE
• 00885556728727: CANNULATED DEPTH GAUGE
• 00885556725351: MULTI PIN GUIDE
• 00885556725276: CANNULATED DEPTH GAUGE
• 00885556725122: CANNULATED BLADE PLATE DRIVER
• 00885556722756: UNIVERSAL SLAP HAMMER W/CHISEL EXTRACTOR
• 00885556718537: K-WIRE DEPTH GAUGE
• 00885556718520: WIRE W/LOOP END
• 00885556718513: COMPRESSION DEVICE NUT
• 00885556718506: KING TONG TENSION NUT
• 00885556717301: 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
• 00885556706329: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 7
• 00885556704776: SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
• 00885556698341: SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
• 00885556696644: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6
• 00885556696637: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5
• 00885556686959: SCREW MEASURING GAUGE FOR 358MM GUIDE WIRES
• 00885556674598: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6
• 00885556674581: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5
• 00885556674116: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5
• 00885556672402: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 7
• 00885556672396: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6
• 00885556672389: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6
• 00885556672372: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5
• 00885556668290: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 6H 4
• 00885556654774: DIRECT MEASURING GAUGE 358MM GUIDE PIN
• 00885556654439: 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE, 4H
• 00885556654224: MODIFIED DIRECT MEASURING GAUGE FOR 3.2MM X 230MM GUIDE PINS
• 00885556653807: 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
• 00885556647035: 130 DEG ADOLESCENT CANNULATED 3.5MM LOCKING BLADE PLATE 4H 7
• 00885556646779: K-WIRE DEPTH GAUGE
• 00885556590737: SS Calcaneal Plate 3H LT
• 00885556590720: SS Calcaneal Plate 3H RT
• 00885556590645: SS Calcaneal Plate 4H RT
• 00885556590577: SS Calcaneal Plate 4H LT
• 00885556590560: SS Pubic Symphysis Locking Plate
• 00885556263242: SLOTTED MALLET
• 00885556226858: INFANT/CHILD BLADE PLATE DRIVER
• 00885556224267: 1.5 X 7 CORT SCR HEX HD STERILE
• 00885556224250: 1.5 X 8 CORT SCR HEX HD STERILE
• 00885556224243: 1.5 X 9 CORT SCR HEX HD STERILE
• 00885556224236: 1.5 X 10 CORT SCR HEX HD STERILE
• 00885556224229: 1.5 X 11 CORT SCR HEX HD STERILE
• 00885556224212: 1.5 X 12 CORT SCR HEX HD STERILE
• 00885556224205: 1.5 X 14 CORT SCR HEX HD STERILE
• 00885556224199: 1.5 X 16 CORT SCR HEX HD STERILE
• 00885556224182: 2.0 X 10ORT SCR HEX HD STERILE
• 00885556224175: 2.0 X 12 CORT SCR HEX HD STERILE
• 00885556224168: 2.0 X 14 CORT HEX HD STERILE