Regenerex SSI001041
GUDID 00889024521018
Biomet Orthopedics, LLC
Bone-resection orthopaedic reamer, reusable| Primary Device ID | 00889024521018 |
| NIH Device Record Key | 544a78c9-40be-4145-9413-d4046a33cd5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Regenerex |
| Version Model Number | SSI001041 |
| Catalog Number | SSI001041 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024521018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060694
FDA Product Code
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
[00889024521018]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-05 |
| Device Publish Date | 2018-10-03 |
On-Brand Devices [Regenerex]
| 00880304479920 | 141269 |
| 00880304478145 | 141277 |
| 00880304474949 | 32-484620 |
| 00880304472655 | 32-484626 |
| 00880304471474 | 32-484606 |
| 00880304471467 | 32-484602 |
| 00880304471450 | 32-484605 |
| 00880304471443 | 32-484607 |
| 00880304471436 | 32-484603 |
| 00880304471429 | 32-484608 |
| 00880304471412 | 32-484601 |
| 00880304471405 | 32-484604 |
| 00880304471382 | 32-484625 |
| 00880304468238 | 32-484623 |
| 00880304468221 | 32-484624 |
| 00880304468214 | 32-484627 |
| 00880304468207 | 32-484622 |
| 00880304468191 | 32-484628 |
| 00880304467088 | 184601 |
| 00880304467057 | 184605 |
| 00880304463646 | 141273 |
| 00880304463639 | 141276 |
| 00880304463622 | 141271 |
| 00880304463615 | 141272 |
| 00880304463608 | 141275 |
| 00880304463592 | 141270 |
| 00880304463585 | 141274 |
| 00880304461970 | 184602 |
| 00880304461963 | 184603 |
| 00880304461956 | 184604 |
| 00880304461949 | 184606 |
| 00880304461932 | 184607 |
| 00880304461925 | 184608 |
| 00889024521018 | SSI001041 |
| 00880304554429 | 141357 |
| 00880304554412 | 141356 |
| 00880304554405 | 141355 |
| 00880304506084 | 141358 |
| 00880304471399 | 32-484615 |
Trademark Results [Regenerex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REGENEREX 78753529 3331701 Live/Registered |
Biomet Manufacturing, LLC 2005-11-14 |
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