WayPoint™ Depth Stop 66-DS-MO
GUDID 10873263005658
WayPoint 1.8mm Depth Stop
FHC, INC.
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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