RENOVATION 71369006

GUDID 03596010437624

CEMENT DRILL 6MM

Smith & Nephew, Inc.

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 03596010437624
• NIH Device Record Key: ba87ead2-6c98-4a5a-bd0e-e62aec38158c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENOVATION
• Version Model Number: 71369006
• Catalog Number: 71369006
• 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	03596010437624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093047

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

[03596010437624]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [RENOVATION]

• 07611996146707: SAWBLADE STRYKER 4/5/6/7 13.4/0.4
• 03596010430137: REVERSE CURETTE 7MM
• 03596010430052: REVERSE CURETTE 9MM
• 03596010407177: REVERSE CURETTE 12MM X 17 IN
• 03596010437631: CONICAL TAP 7MM
• 03596010437624: CEMENT DRILL 6MM
• 03596010437471: RENOVATION FEMORAL IMPLANT REMOVAL TRAY INSERT 2
• 03596010437464: RENOVATION FEMORAL IMPLANT REMOVAL TRAY INSERT 1
• 03596010437457: RENOVATION FEMORAL IMPLANT REMOVAL TRAY
• 03596010437440: RENOVATION ACETABULAR IMPLANT TRAY REMOVAL INSERT
• 03596010437433: RENOVATION ACETABULAR IMPLANT REMOVAL TRAY
• 03596010427588: ANGLED GOUGE
• 03596010407207: X OSTEOTOME 7MM X 17 IN
• 03596010407191: CARBIDE PUNCH
• 03596010407184: CHISEL 8MM X 17 IN
• 03596010403063: FIXED HEAD STEM EXTRACTOR
• 03596010403056: HOOK STEM EXTRACTOR
• 03596010403049: T-HANDLE WRENCH
• 03596010403032: MODULAR STEM EXTRACTOR
• 03596010403025: LARGE SLAP HAMMER
• 03596010403018: SLOTTED MALLET
• 03596010402974: THIN OSTEOTOME BLADE 8MM X 5 IN
• 03596010402967: THIN OSTEOTOME BLADE 10MM X 5 IN
• 03596010402950: THIN OSTEO BLD ROUND END 20MM
• 03596010402943: THIN OSTEOTOME BLADE ROUNDED END 20MM
• 03596010402936: THIN OSTEOTOME BLADE 20MM X 3 IN
• 03596010402929: THIN OSTEOTOME BLADE 12MM X 3 IN
• 03596010402912: THIN OSTEOTOME BLADE 10MM X 3 IN
• 03596010402905: THIN OSTEOTOME BLADE 8MM X 3 IN
• 03596010402899: RADIAL OSTEOTOME BLADE SIZE 16
• 03596010402882: RADIAL OSTEOTOME BLADE SIZE 14
• 03596010402875: RADIAL OSTEOTOME BLADE SIZE 12
• 03596010402868: RADIAL OSTEOTOME BLADE SIZE 10
• 03596010402776: ROUND ACETABULAR CEMENT SPLITTER
• 03596010402769: CURVED ACETABULAR CHISEL
• 03596010402752: ACETABULAR COMPONENT FORCEPS
• 03596010402745: ACETABULAR COMPONENT GRIPPER
• 03596010402738: SMALL SLAP HAMMER
• 03596010402721: OSTEOTOME SYSTEM TRAY INSERT
• 03596010403100: RENOVATION CEMENT DRILL 8MM
• 03596010403087: RENOVATION CONICAL TAP 11MM
• 03596010403094: CONICAL TAP 13MM
• 03596010403070: CONICAL TAP 9MM
• 03596010437617: CEMENT DRILL 4.5MM
• 03596010406415: RONGEUR 300MM WITH TEETH
• 03596010406408: RONGEUR 200MM WITH TEETH
• 03596010406392: STRAIGHT GOUGE
• 03596010406378: FLAG SPLITTER
• 03596010403131: V SPLITTER
• 03596010402851: SMALL ACETABULAR GOUGE