CATALYSTEM 71314211
GUDID 00885556892213
CATALYSTEM BROACH SIZE 11
Smith & Nephew, Inc.
Orthopaedic broach| Primary Device ID | 00885556892213 |
| NIH Device Record Key | acf35f15-5900-4649-9784-2bfa9f4aa38b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CATALYSTEM |
| Version Model Number | 71314211 |
| Catalog Number | 71314211 |
| Company DUNS | 045483575 |
| 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)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556892213 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123598
FDA Product Code
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
[00885556892213]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-07 |
| Device Publish Date | 2024-07-30 |
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 |
Trademark Results [CATALYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATALYSTEM 98178393 not registered Live/Pending |
Smith & Nephew, Inc. 2023-09-13 |
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