WayPoint™ Depth Stop 66-DS-MO
GUDID 10873263005658
WayPoint 1.8mm Depth Stop
FHC, INC.
Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system| Primary Device ID | 10873263005658 |
| NIH Device Record Key | f7b698bc-eb04-441c-96af-7853234b32f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WayPoint™ Depth Stop |
| Version Model Number | 66-DS-MO-00565 |
| Catalog Number | 66-DS-MO |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 2 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com |
Device Dimensions
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 1.8 Millimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263005651 [Unit of Use] |
| GS1 | 10873263005658 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092192
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
[10873263005658]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2016-12-28 |
On-Brand Devices [WayPoint™ Depth Stop]
| 00873263005446 | WayPoint 1.8mm Depth Stop |
| 10873263005658 | WayPoint 1.8mm Depth Stop |
Trademark Results [WayPoint]
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