| Primary Device ID | 04719886894271 |
| NIH Device Record Key | e53c3617-e273-402d-ad86-53a011e3aa23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Full XPE Cup |
| Version Model Number | 9203-1343 |
| Catalog Number | 9203-1343 |
| Company DUNS | 656700556 |
| Company Name | UNITED ORTHOPEDIC CORP. |
| 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 | true |
| 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 |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com | |
| Phone | +886229294567 |
| tw.service@unitedorthopedic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719886894271 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
[04719886894271]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
| 04711605579247 | Full XPE cup, ID 32mm, OD 62mm |
| 04711605579230 | Full XPE cup, ID 32mm, OD 60mm |
| 04711605579223 | Full XPE cup, ID 32mm, OD 58mm |
| 04711605579216 | Full XPE cup, ID 32mm, OD 56mm |
| 04711605579209 | Full XPE cup, ID 32mm, OD 54mm |
| 04711605579193 | Full XPE cup, ID 32mm, OD 52mm |
| 04711605573740 | Full XPE cup, ID 26mm, OD 42mm |
| 04711605568869 | Full XPE cup, ID 36mm, OD 62mm |
| 04711605568852 | Full XPE cup, ID 36mm, OD 60mm |
| 04711605568845 | Full XPE cup, ID 36mm, OD 58mm |
| 04711605568838 | Full XPE cup, ID 36mm, OD 56mm |
| 04711605568821 | Full XPE cup, ID 36mm, OD 54mm |
| 04711605568814 | Full XPE cup, ID 36mm, OD 52mm |
| 04711605568807 | Full XPE cup, ID 32mm, OD 50mm |
| 04711605568791 | Full XPE cup, ID 32mm, OD 48mm |
| 04711605568784 | Full XPE cup, ID 28mm, OD 46mm |
| 04711605568777 | Full XPE cup, ID 28mm, OD 44mm |
| 04719886894349 | Cup pusher head, 36mm |
| 04719886894332 | Cup pusher head, 32mm |
| 04719886894325 | Cup pusher head, 28mm |
| 04719886894295 | Curved cup pusher |
| 04719886894288 | Positioner plate, L |
| 04719886894271 | Positioner plate, M |
| 04719886894264 | Positioner plate, S |
| 04719886894257 | Positioner plate, XS |
| 04719886894240 | Positioner head, L |
| 04719886894233 | Positioner head, M |
| 04719886894226 | Positioner head, S |
| 04719886894219 | Positioner head, XS |
| 04719886894202 | Full XPE cup positioner handle |
| 04719872142119 | Full XPE cup tray |