OptimalMTP™ 6102.2116
GUDID 00810136432954
1.6mm Olive K-wire, 4 in. Long
Forma Medical, Inc.
Orthopaedic guidewire, single-use| Primary Device ID | 00810136432954 |
| NIH Device Record Key | eab72389-b9dd-41eb-b660-a4c1144ea4dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptimalMTP™ |
| Version Model Number | 6102.2116 |
| Catalog Number | 6102.2116 |
| Company DUNS | 126585966 |
| Company Name | Forma Medical, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com | |
| Phone | 0000000000 |
| support@formamedical.com |
Device Dimensions
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
| Outer Diameter | 1.6 Millimeter |
| Length | 4 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810136432954 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230945
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
[00810136432954]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
On-Brand Devices [OptimalMTP™]
| 00810136432954 | 1.6mm Olive K-wire, 4 in. Long |
| 00810136432947 | 1.4mm Olive K-wire, 4 in. Long |
| 00810136433425 | RADIOLUCENT POSITIONING WEDGE, RIGHT, 10 DEGREES |
| 00810136433418 | RADIOLUCENT POSITIONING WEDGE, RIGHT, 5 DEGREES |
| 00810136433401 | RADIOLUCENT POSITIONING WEDGE, LEFT, 10 DEGREES |
| 00810136433395 | RADIOLUCENT POSITIONING WEDGE, LEFT, 5 DEGREES |
| 00810136433388 | Radiolucent Foot Plate |
Trademark Results [OptimalMTP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIMALMTP 98097311 not registered Live/Pending |
Forma Medical, Inc. 2023-07-22 |
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