BIOLOX delta 71325175

GUDID 00885556499245

R3 US DELTA HEAD 36 +4

Smith & Nephew, Inc.

Ceramic femoral head prosthesis

• Primary Device ID: 00885556499245
• NIH Device Record Key: a55647f7-1f22-444b-8c35-46c2697cefbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX delta
• Version Model Number: 71325175
• Catalog Number: 71325175
• 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
• 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	00885556499245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150030

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: 2017-06-01

On-Brand Devices [BIOLOX delta]

• 00885556499290: R3 US DELTA HEAD 36 +8
• 00885556499245: R3 US DELTA HEAD 36 +4
• 00885556499191: R3 US DELTA HEAD 36 +0
• 00885556499146: R3 US DELTA HEAD 32 +8
• 00885556499092: R3 US DELTA HEAD 32 +4
• 00885556499047: R3 US DELTA HEAD 32 +0
• 00885556498996: R3 36MM ID US DELTA LINER 66 68MM OD
• 00885556498941: R3 36MM ID US DELTA LINER 64MM OD
• 00885556498897: R3 36MM ID US DELTA LINER 62MM OD
• 00885556498842: R3 36MM ID US DELTA LINER 60MM OD
• 00885556498798: R3 36MM ID US DELTA LINER 58MM OD
• 00885556498743: R3 36MM ID US DELTA LINER 56MM OD
• 00885556498699: R3 36MM ID US DELTA LINER 54MM OD
• 00885556498644: R3 36MM ID US DELTA LINER 52MM OD
• 00885556498590: R3 32MM ID US DELTA LINER 50MM OD
• 00885556498545: R3 32MM ID US DELTA LINER 48MM OD
• 03596010656735: BIOLOX DELTA HEAD 40MM 12/14 LONG +8
• 03596010656728: BIOLOX DELTA HEAD 40MM 12/14 MEDIUM +4
• 03596010656711: BIOLOX DELTA HEAD 40MM 12/14 SHORT+0
• 03596010566966: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• 03596010566973: BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8
• 03596010566959: BIOLOX DELTA HEAD 36 MM 12/14 SHORT / +0
• 03596010566942: BIOLOX DELTA HEAD 32 MM 12/14 LONG / +8
• 03596010566935: BIOLOX DELTA HEAD 32 MM 12/14 MEDIUM / +4
• 03596010566928: BIOLOX DELTA HEAD 32 MM 12/14 SHORT / +0