OptimalHT™

GUDID 50810136430375

Cobalt Chrome 1.4mm K-wire

Forma Medical, Inc.

Orthopaedic guidewire, single-use

Primary Device ID	50810136430375
NIH Device Record Key	b777405d-ea6f-4ae1-a62f-2c1d26adee03
Commercial Distribution Status	In Commercial Distribution
Brand Name	OptimalHT™
Version Model Number	6100.2114
Company DUNS	126585966
Company Name	Forma Medical, Inc.
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	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com
Phone	0000000000
Email	support@formamedical.com

Device Dimensions

Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter
Outer Diameter	1.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136430370 [Primary]
GS1	50810136430375 [Package] Contains: 00810136430370 Package: [5 Units] In Commercial Distribution

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

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

[50810136430375]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-12-28
Device Publish Date	2023-12-20

On-Brand Devices [OptimalHT™]

00810136430622	MIS Targeting Instrument, Radiopaque, 1.1mm Wire, Offset
00810136430615	OptimalHT 2.0 1.3mm Drill, AO Quick Connect, Solid
00810136430608	OptimalHT 2.0 T7 Hexalobe, AO Quick Connect, Solid
00810136430592	OptimalHT 2.0 MIS Targeting Device, Wire-Free
00810136430585	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 42MM LONG
00810136430578	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 40MM LONG
00810136430561	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 38MM LONG
00810136430554	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 36MM LONG
00810136430547	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 35MM LONG
00810136430530	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 34MM LONG
00810136430523	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 32MM LONG
00810136430516	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 30MM LONG
00810136430509	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 28MM LONG
00810136430493	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 26MM LONG
00810136430486	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 25MM LONG
00810136430479	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 24MM LONG
00810136430462	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 22MM LONG
00810136430455	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 20MM LONG
00810136430448	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 18MM LONG
00810136430431	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 16MM LONG
00810136430424	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 15MM LONG
00810136430417	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 14MM LONG
00810136430400	1.9MM SOLID HEADLESS COMPRESSION SCREW, CANCELLOUS HEAD, 12MM LONG
00810136430394	MIS Targeting Instrument, Handled, 1.4mm Wire, With Elevator
00810136430387	Cannulated Depth Gauge
50810136430375	Cobalt Chrome 1.4mm K-wire
50810136430368	Stainless Steel 1.4mm K-wire
00810136430356	MIS Targeting Instrument, Handled, 1.1mm Wire, With Elevator
00810136430349	MIS Targeting Instrument, Radiopaque, 1.1mm Wire, In-line
00810136430332	MIS Targeting Instrument, Handled, 1.4mm Wire
50810136430184	Cobalt Chrome 1.1mm K-wire, 4 in. long with depth marking
00810136430011	MIS Targeting Instrument, Handled, 0.9mm wire
00810136430288	2.5mm Headless Compression Screws, Cancellous Head, 40mm long
00810136430271	2.5mm Headless Compression Screws, Cancellous Head, 35mm long
00810136430264	2.5mm Headless Compression Screws, Cancellous Head, 30mm long
00810136430257	2.5mm Headless Compression Screws, Cancellous Head, 25mm long
00810136430240	2.5mm Headless Compression Screws, Cancellous Head, 20mm long
00810136430233	2.0mm Headless Compression Screws, Cancellous Head, 40mm long
00810136430226	2.0mm Headless Compression Screws, Cancellous Head, 35mm long
00810136430219	2.0mm Headless Compression Screws, Cancellous Head, 30mm long
00810136430202	2.0mm Headless Compression Screws, Cancellous Head, 25mm long
00810136430196	2.0mm Headless Compression Screws, Cancellous Head, 20mm long
50810136430177	Cobalt Chrome 0.9mm K-wire, 4 in. long with depth marking
50810136430160	Stainless Steel 1.1mm K-wire 4 in. long with depth marking
50810136430153	Stainless Steel 0.9mm K-wire, 4 in. long with depth marking
00810136430134	MIS Targeting Instrument, Handled with Elevator, 0.9mm Wire
00810136430127	Burr, Hammertoe Specific
00810136430110	1.9mm Drill, AO Quick Connect, Cannulated
00810136430103	1.7mm Drill, AO Quick Connect, Cannulated
00810136430097	2.5mm Driver, T8 Hexalobe, AO Quick Connect, Cannulated

Trademark Results [OptimalHT]

Mark Image Registration \| Serial	Company Trademark Application Date
OPTIMALHT 98097309 not registered Live/Pending	Forma Medical, Inc. 2023-07-22

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