Neurgain
- Primary DI
- 00850059514016
- Brand
- Neurgain
- Company
- Neurgain Technologies, Inc.
- Model
- NGN-9002
- Device description
- XYZ Manipulator
- Published
- 2024-11-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| HAO | Instrument, Surgical, Non-Powered |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850059514016 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850059514016 | 00850059514016 | 850059514016 | 0850059514016 |
GMDN Terms#
| Term | Definition |
|---|---|
| Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. |
Sterilization Methods#
| Method |
|---|
| "[""Hydrogen Peroxide"", ""Ethylene Oxide""]" |
| Hydrogen Peroxide;Ethylene Oxide |
Regulatory Flags#
- DUNS number
- 081264051
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- Serial number
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850059514009 | Neurgain | NGN-9001 | 2024-11-20 | |
| 00850059514023 | Neurgain | NGN-9005 | 2024-11-20 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G586N93065370 | Novo Surgical | NOVO SURGICAL, INC. | HAO | 2024-02-22 |
| G586N93065380 | Novo Surgical | NOVO SURGICAL, INC. | HAO | 2024-02-22 |
| G28435301 | Screwdriver | Neurovention LLC | HAO | 2022-06-21 |
| 07613327262322 | XIA | Stryker Corporation | HAO | 2019-11-21 |
| 07613327264432 | XIA 4.5 | Stryker Corporation | HAO | 2019-11-21 |
| 07613327264951 | XIA 3 | Stryker Corporation | HAO | 2019-11-21 |
| 07613327271447 | OASYS | Stryker Corporation | HAO | 2019-11-21 |
| 07613327276176 | RADIUS | Stryker Corporation | HAO | 2019-11-21 |
| 07613327263787 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
| 07613327263923 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
| 07613327265897 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
| 07613327265910 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
| 07613327265934 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
| 07613327266016 | RELIANCE LITe | Stryker Corporation | HAO | 2019-11-20 |
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