DELTA XTEND 230720111
GUDID 10603295518808
DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 1
DEPUY (IRELAND)
Humeral stem prosthesis trial Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable Humeral stem prosthesis trial, reusable| Primary Device ID | 10603295518808 |
| NIH Device Record Key | 126338bd-5823-4e53-9229-a513b790906b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DELTA XTEND |
| Version Model Number | 2307-20-111 |
| Catalog Number | 230720111 |
| Company DUNS | 989365556 |
| Company Name | DEPUY (IRELAND) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295518808 [Primary] |
FDA Product Code
| HWT | TEMPLATE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
[10603295518808]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |
On-Brand Devices [DELTA XTEND]
| 10603295507147 | DELTA XTEND 145 Degree EPI / LATERALIZED LID |
| 10603295507130 | DELTA XTEND 145 Degree EPI / LATERALIZED CASE |
| 10603295507345 | DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 42mm |
| 10603295507338 | DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 42mm |
| 10603295507321 | DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 42mm |
| 10603295507314 | DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 42mm |
| 10603295507307 | DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 42mm |
| 10603295507291 | DELTA XTEND Lateralized Glenosphere +8mm Trial Standard diameter 38mm |
| 10603295507284 | DELTA XTEND Lateralized Glenosphere +6mm Trial Standard diameter 38mm |
| 10603295507277 | DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 38mm |
| 10603295507260 | DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 38mm |
| 10603295507253 | DELTA XTEND Lateralized Glenosphere +4mm Trial Standard diameter 38mm |
| 10603295507246 | DELTA XTEND Lateralized Glenosphere +2mm Trial Standard diameter 38mm |
| 10603295507239 | DELTA XTEND Lateralized Glenosphere +0mm Trial Standard diameter 38mm |
| 10603295507222 | DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 42mm |
| 10603295507215 | DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 42mm |
| 10603295507208 | DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 42mm |
| 10603295507192 | DELTA XTEND Lateralized Glenosphere +2mm Trial Eccentric diameter 42mm |
| 10603295507185 | DELTA XTEND Lateralized Glenosphere +0mm Trial Eccentric diameter 42mm |
| 10603295507178 | DELTA XTEND Lateralized Glenosphere +8mm Trial Eccentric diameter 38mm |
| 10603295507161 | DELTA XTEND Lateralized Glenosphere +6mm Trial Eccentric diameter 38mm |
| 10603295507154 | DELTA XTEND Lateralized Glenosphere +4mm Trial Eccentric diameter 38mm |
| 10603295502647 | DELTA XTEND Lateralized Glenosphere +6mm Eccentric 042mm |
| 10603295502630 | DELTA XTEND Lateralized Glenosphere +6mm Eccentric 038mm |
| 10603295502623 | DELTA XTEND Lateralized Glenosphere +6mm Standard 042mm |
| 10603295502616 | DELTA XTEND Lateralized Glenosphere +6mm Standard 038mm |
| 10603295502609 | DELTA XTEND Lateralized Glenosphere +0mm Eccentric 042mm |
| 10603295502593 | DELTA XTEND Lateralized Glenosphere +0mm Eccentric 038mm |
| 10603295502562 | DELTA XTEND Lateralized Glenosphere +0mm Standard 042mm |
| 10603295502555 | DELTA XTEND Lateralized Glenosphere +0mm Standard 038mm |
| 10603295502548 | DELTA XTEND Lateralized Glenosphere +8mm Standard 042mm |
| 10603295502531 | DELTA XTEND Lateralized Glenosphere +8mm Standard 038mm |
| 10603295502524 | DELTA XTEND Lateralized Glenosphere +8mm Eccentric 042mm |
| 10603295502517 | DELTA XTEND Lateralized Glenosphere +8mm Eccentric 038mm |
| 10603295502500 | DELTA XTEND Lateralized Glenosphere +2mm Standard 042mm |
| 10603295502494 | DELTA XTEND Lateralized Glenosphere +2mm Standard 038mm |
| 10603295502487 | DELTA XTEND Lateralized Glenosphere +4mm Eccentric 042mm |
| 10603295502470 | DELTA XTEND Lateralized Glenosphere +4mm Eccentric 038mm |
| 10603295502463 | DELTA XTEND Lateralized Glenosphere +4mm Standard 042mm |
| 10603295502456 | DELTA XTEND Lateralized Glenosphere +4mm Standard 038mm |
| 10603295502449 | DELTA XTEND Lateralized Glenosphere +2mm Eccentric 042mm |
| 10603295502432 | DELTA XTEND Lateralized Glenosphere +2mm Eccentric 038mm |
| 10603295423652 | DELTA XTEND Cementless Metaglene +15mm HA |
| 10603295423645 | DELTA XTEND Cementless Metaglene +10mm HA |
| 10603295518853 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 2 |
| 10603295518846 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 2 |
| 10603295518839 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL RIGHT Size 1 |
| 10603295518822 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL LEFT Size 1 |
| 10603295518815 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 2 |
| 10603295518808 | DELTA XTEND MODULAR ECCENTRIC 145 EPIPHYSIS TRIAL CENTERED Size 1 |
Trademark Results [DELTA XTEND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DELTA XTEND 88923776 not registered Live/Pending |
Depuy Synthes, Inc. 2020-05-19 |
 DELTA XTEND 78770907 not registered Dead/Abandoned |
DePuy, Inc. 2005-12-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.