SOLUSTAPLE 114004ND
GUDID M248114004ND1
The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available (90 or 116 degrees interaxis). In order to safeguard the function of the joint, the staple with oblique design will be used. It is made out of stainless steel, and it is delivered non sterile.
NEWDEAL
Orthopaedic bone staple, non-adjustable| Primary Device ID | M248114004ND1 |
| NIH Device Record Key | b75d96af-6625-4104-842d-9e8495b51e97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLUSTAPLE |
| Version Model Number | 114004ND |
| Catalog Number | 114004ND |
| 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 | |
| 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 | 10381780052388 [Primary] |
| HIBCC | M248114004ND1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991566
FDA Product Code
| JDR | STAPLE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
[M248114004ND1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-01-27 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [SOLUSTAPLE]
| 10381780052432 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| 10381780052418 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| 10381780052395 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| 10381780052371 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| M248114025ND1 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| M248114023ND1 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| M248114004ND1 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
| M248114002ND1 | The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, a |
Trademark Results [SOLUSTAPLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLUSTAPLE 75717451 2610140 Dead/Cancelled |
NEWDEAL 1999-06-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.