ORTHOMATCH 71442174

GUDID 00885556531785

ORTHOMATCH MODULAR BOX CHISEL

Smith & Nephew, Inc.

Orthopaedic chisel

• Primary Device ID: 00885556531785
• NIH Device Record Key: 375e75ef-54bc-45b4-86ef-2135eeb0d408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOMATCH
• Version Model Number: 71442174
• Catalog Number: 71442174
• 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
• 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	00885556531785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142807

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

[00885556531785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-28

On-Brand Devices [ORTHOMATCH]

• 00885556707289: ORTHOMATCH GII TIBIAL PREP & TRIALS TRAY SZ 1-6
• 00885556659823: ORTHOMATCH FEMORAL SIZER POSTERIOR REF
• 00885556659816: ORTHOMATCH FEMORAL SIZER ANTERIOR REF
• 00885556626108: GII PLASTIC FEM TRIAL PANEL 7-8
• 00885556625910: GII PLASTIC REAMTHRU FEM TRL SZ 8 RT
• 00885556625903: GII PLASTIC REAMTHRU FEM TRL SZ 8 LT
• 00885556625897: GII PLASTIC REAMTHRU FEM TRL SZ 7 RT
• 00885556625880: GII PLASTIC REAMTHRU FEM TRL SZ 7 LT
• 00885556625873: GII PLASTIC REAMTHRU FEM TRL SZ 6 RT
• 00885556625866: GII PLASTIC REAMTHRU FEM TRL SZ 6 LT
• 00885556625859: GII PLASTIC REAMTHRU FEM TRL SZ 5 RT
• 00885556625842: GII PLASTIC REAMTHRU FEM TRL SZ 5 LT
• 00885556625835: GII PLASTIC REAMTHRU FEM TRL SZ 4 RT
• 00885556625828: GII PLASTIC REAMTHRU FEM TRL SZ 4 LT
• 00885556625811: GII PLASTIC REAMTHRU FEM TRL SZ 3 RT
• 00885556625804: GII PLASTIC REAMTHRU FEM TRL SZ 3 LT
• 00885556625798: GII PLASTIC REAMTHRU FEM TRL SZ 2 RT
• 00885556625781: GII PLASTIC REAMTHRU FEM TRL SZ 2 LT
• 00885556625774: GII PLASTIC REAMTHRU FEM TRL SZ 1 RT
• 00885556625767: GII PLASTIC REAMTHRU FEM TRL SZ 1 LT
• 00885556625354: GII FEMORAL TRIALS L TRAY PANEL SZ 1-6
• 00885556622087: ORTHOMATCH CR IMPLANT IMPACTOR
• 00885556622056: ORTHOMATCH GII TRAPEZOIDAL SPACER
• 00885556618189: ORTHOMATCH MODULAR CR LUG PUNCH
• 00885556583791: ORTHOMATCH MOD FEMORAL TRIAL IMPACTOR
• 00885556583784: ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR
• 00885556583777: ORTHOMATCH TIB BASE PLATE ALIGN BULLET
• 00885556583760: ORTHOMATCH EM ALIGNMENT DROP ROD GUIDE
• 00885556583753: ORTHOMATCH TIB CUT BLOCK 3 DEG CONNECTOR
• 00885556583746: ORTHOMATCH FEMORAL A/P SIZER
• 00885556583739: ORTHOMATCH DCF ALIGNMENT GUIDE
• 00885556582916: ORTHOMATCH ANTR REF A/P TRSLTN GUIDE
• 00885556581346: ORTHOMATCH PSTR REF A/P TRSLTN GUIDE
• 00885556531785: ORTHOMATCH MODULAR BOX CHISEL
• 00885556531761: ORTHOMATCH MODLR PS FEM IMPLANT IMPACTOR
• 00885556498101: ORTHOMATCH MODULAR FIN PUNCH SZ 7-8
• 00885556498057: ORTHOMATCH MODULAR FIN PUNCH SZ 5-6
• 00885556498002: ORTHOMATCH MODULAR FIN PUNCH SZ 3-4
• 00885556497951: ORTHOMATCH MODULAR FIN PUNCH SZ 1-2
• 00885556497906: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 8 RT
• 00885556497852: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 8 LT
• 00885556497807: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 7 RT
• 00885556497753: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 7 LT
• 00885556497708: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 6 RT
• 00885556497654: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 6 LT
• 00885556497609: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 5 RT
• 00885556497555: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 5 LT
• 00885556497500: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 4 RT
• 00885556497456: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 4 LT
• 00885556497401: ORTHOMATCH STEMLESS TIBIAL TRIAL SZ 3 RT