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

• 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