NeuroPEN
GUDID 00613994908490
NEUROPEN 2120-035 15MM 19CM DF
MEDTRONIC PS MEDICAL, INC.
Rigid optical neuroscope, single-use Rigid optical neuroscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use Rigid optical intracranial/spinal endoscope, single-use| Primary Device ID | 00613994908490 |
| NIH Device Record Key | 7aa9efa2-a03a-4acc-9e69-07fccc4d4f4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuroPEN |
| Version Model Number | 2120-035 |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS 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 | false |
| 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
Device Dimensions
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
| Length | 19 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994908490 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003914
FDA Product Code
| GWG | ENDOSCOPE, NEUROLOGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-06-13 |
On-Brand Devices [NeuroPEN]
| 00613994908490 | NEUROPEN 2120-035 15MM 19CM DF |
| 00613994840233 | NEUROPEN 2120-025 15MM 15.5 DF .045 |
| 00643169498051 | FORCEPS 3220-001 BIOPSY 3MM L 28.5CM |
| 00721902879784 | NEUROPEN 27769 W/NO EPOXY OVER END |
Trademark Results [NeuroPEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROPEN 75292296 2215863 Live/Registered |
Owen Mumford Limited 1997-05-15 |
 NEUROPEN 75082984 2037241 Dead/Cancelled |
Clarus Medical Systems, Inc. 1996-04-03 |
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