BIOLOX FORTE CERAMIC 71332085

GUDID 00885556020241

BIOLOX FORTE US FEMORAL HEAD 36MM M+4 12/14 TPR +4

Smith & Nephew, Inc.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 00885556020241
• NIH Device Record Key: dca4de92-ea4b-4cab-b4ee-bd43c1973457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX FORTE CERAMIC
• Version Model Number: 71332085
• Catalog Number: 71332085
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556020241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030022

FDA Product Code

• MRA: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-05-06

On-Brand Devices [BIOLOX FORTE CERAMIC]

• 00885556021644: BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +8
• 00885556021248: BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +4
• 00885556020869: BIOLOX FORTE CERAMIC 32MM FEM HEAD 12/14 TAPER +0
• 00885556020838: BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +0
• 00885556020531: BIOLOX FORTE US FEMORAL HEAD 36MM L/+8 12/14 TPR
• 00885556020241: BIOLOX FORTE US FEMORAL HEAD 36MM M+4 12/14 TPR +4
• 00885556019993: BIOLOX FORTE CERAMIC 28MM FEMORAL HEAD 12/14 TPR +8
• 00885556019849: BIOLOX FORTE US FEMORAL HEAD 36MM S/+0 12/14 TPR
• 00885556019726: BIOLOX FORTE CERAMIC 28MM FEM HEAD 12/14 TAPER +4