CATALYSTEM 71314088

GUDID 00885556892039

CATALYSTEM COLLARLESS STEM HIGH OFFSET SIZE 8

Smith & Nephew, Inc.

Coated hip femur prosthesis, modular

• Primary Device ID: 00885556892039
• NIH Device Record Key: 98541384-4878-4036-8156-68646680b197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CATALYSTEM
• Version Model Number: 71314088
• Catalog Number: 71314088
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556892039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240381

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-03
• Device Publish Date: 2024-08-26

On-Brand Devices [CATALYSTEM]

• 00885556913857: CATALYSTEM BROACH HANDLE OUTER TRAY
• 00885556913840: CATALYSTEM SINGLE OFFSET INSTRUMENT TRAY
• 00885556908938: CATALYSTEM STARTER BROACH
• 00885556908907: CATAYLSTEM OFFSET INSERTER
• 00885556892343: CATALYSTEM DUAL OFFSET INSTRUMENT TRAY
• 00885556892336: CATALYSTEM STRAIGHT BROACH HANDLE INSTRUMENT TRAY
• 00885556892329: CATALYSTEM DA BROACH HANDLE INSTRUMENT TRAY
• 00885556892312: CATALYSTEM CORE INSTRUMENT TRAY
• 00885556892268: CATALYSTEM TRIAL NECK SIZE 7-12 HIGH OFFSET
• 00885556892251: CATALYSTEM TRIAL NECK SIZE 0-6 HIGH OFFSET
• 00885556892244: CATALYSTEM TRIAL NECK SIZE 7-12 STANDARD OFFSET
• 00885556892237: CATALYSTEM TRIAL NECK SIZE 0-6 STANDARD OFFSET
• 00885556892220: CATALYSTEM BROACH SIZE 12
• 00885556892213: CATALYSTEM BROACH SIZE 11
• 00885556892206: CATALYSTEM BROACH SIZE 10
• 00885556892190: CATALYSTEM BROACH SIZE 9
• 00885556892183: CATALYSTEM BROACH SIZE 8
• 00885556892176: CATALYSTEM BROACH SIZE 7
• 00885556892169: CATALYSTEM BROACH SIZE 6
• 00885556892152: CATALYSTEM BROACH SIZE 5
• 00885556892145: CATALYSTEM BROACH SIZE 4
• 00885556892138: CATALYSTEM BROACH SIZE 3
• 00885556892121: CATALYSTEM BROACH SIZE 2
• 00885556892114: CATALYSTEM BROACH SIZE 1
• 00885556892107: CATALYSTEM BROACH SIZE 0
• 00885556891759: CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
• 00885556891742: CATALYSTEM COLLARED HIGH OFFSET SIZE 5
• 00885556891735: CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 4
• 00885556891629: CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 6
• 00885556891612: CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 5
• 00885556891605: CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 4
• 00885556891865: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 4
• 00885556891858: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 3
• 00885556891841: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 2
• 00885556891834: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 1
• 00885556891827: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 0
• 00885556891988: CATALYSTEM COLLARLESS STEM HIGH OFFSET SIZE 3
• 00885556891971: CATALYSTEM COLLARLESS STEM HIGH OFFSET SIZE 1
• 00885556891964: CATALYSTEM COLLARLESS STEM HIGH OFFSET SIZE 2
• 00885556891957: CATALYSTEM COLLARLESS HIGH STEM OFFSET SIZE 0
• 00885556891940: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 12
• 00885556891933: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 11
• 00885556891926: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 10
• 00885556891919: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 9
• 00885556891902: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 8
• 00885556891896: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 7
• 00885556891872: CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 5
• 00885556891810: CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 12
• 00885556891797: CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 10
• 00885556891780: CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 9