SNAP-OFF 117032ND
GUDID M248117032ND1
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | M248117032ND1 |
| NIH Device Record Key | 5c69a13a-b92a-488c-8422-9374b8ac9692 |
| Commercial Distribution Discontinuation | 2027-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SNAP-OFF |
| Version Model Number | 117032ND |
| Catalog Number | 117032ND |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 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 |
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 |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780047698 [Primary] |
| HIBCC | M248117032ND1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021626
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248117032ND1]
Moist Heat or Steam Sterilization
[M248117032ND1]
Moist Heat or Steam Sterilization
[M248117032ND1]
Moist Heat or Steam Sterilization
[M248117032ND1]
Moist Heat or Steam Sterilization
[M248117032ND1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [SNAP-OFF]
| 10381780047865 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047858 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047841 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047834 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047827 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047810 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047803 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047797 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047780 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B- |
| 10381780047773 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047766 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117112ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047742 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117110ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047728 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047711 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047704 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117032ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047681 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117030ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047667 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047650 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047643 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047636 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047629 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047612 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047605 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117022ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047582 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117020ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047568 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047551 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047544 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047537 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047520 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117014ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047506 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117012ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| 10381780047483 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
| M248117010ND1 | The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla |
Trademark Results [SNAP-OFF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SNAP-OFF 78083526 2639738 Dead/Cancelled |
International Engineering & Manufacturing Inc. 2001-09-12 |
 SNAP-OFF 76596818 3022591 Dead/Cancelled |
WORLDWIDE INTEGRATED RESOURCES, INC. 2004-06-09 |
 SNAP-OFF 76067848 not registered Dead/Abandoned |
Kady, Darren J 2000-06-12 |
 SNAP-OFF 75380377 2245220 Dead/Cancelled |
WORLDWIDE INTEGRATED RESOURCES, INC. 1997-10-28 |
 SNAP-OFF 75148318 not registered Dead/Abandoned |
WORLDWIDE INTEGRATED RESOURCES, INC. 1996-08-12 |
 SNAP-OFF 74561004 not registered Dead/Abandoned |
PLAS-PAK INDUSTRIES, INC. 1994-08-15 |
 SNAP-OFF 74050211 1647416 Live/Registered |
Wallace Computer Services, Inc. 1990-04-18 |
 SNAP-OFF 73582343 1423474 Dead/Cancelled |
PAUL FLUM IDEAS, INC. 1986-02-07 |
 SNAP-OFF 72077757 0701163 Dead/Cancelled |
LION PACKAGING PRODUCTS CO., INC. 1959-07-15 |
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