PANTA 500080ND
GUDID M248500080ND1
The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail allow for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long. The nail is made from Titanium alloy.
NEWDEAL
Arthrodesis nail| Primary Device ID | M248500080ND1 |
| NIH Device Record Key | 52638ce5-27b6-4e5b-95d1-30a83352f805 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PANTA |
| Version Model Number | 500080ND |
| Catalog Number | 500080ND |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780044505 [Primary] |
| HIBCC | M248500080ND1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091788
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [PANTA]
| 10381780044482 | The end cap is made from Titanium alloy and may be inserted into the distal nail threads to prev |
| 10381780044567 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500350ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| 10381780044543 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500250ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500180ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500150ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500080ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| M248500050ND1 | The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 1 |
| 10381780125860 | The PANTA nail set inclides instrumentation wich are used as a guide for the implantation of PAN |
| 10381780125891 | The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail |
Trademark Results [PANTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PANTA 97180364 not registered Live/Pending |
Iris Restaurant Group 2021-12-20 |
 PANTA 88776510 not registered Live/Pending |
VIP Products L.L.C. 2020-01-28 |
 PANTA 88548512 not registered Live/Pending |
NINGBO XINMAI EXHIBITION EQUIPMENT CO.,LTD 2019-07-30 |
 PANTA 85006649 4152440 Live/Registered |
Sumida flexible connections GmbH 2010-04-05 |
 PANTA 79230375 not registered Live/Pending |
PANTAFLIX AG 2017-09-13 |
 PANTA 79018294 3168990 Live/Registered |
NEWDEAL 2005-09-26 |
 PANTA 78485363 3160179 Dead/Cancelled |
Panta Systems, Inc. 2004-09-17 |
 PANTA 78485355 3130908 Dead/Cancelled |
Panta Systems, Inc. 2004-09-17 |
 PANTA 73567136 1476904 Dead/Cancelled |
PANTASHOP 1985-11-06 |
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