NeuGuide™ FG0001
GUDID 07290017082004
The NeuGuide™ is a single use trans-vaginal device for the repair of pelvic organ prolapse (POP) by anchoring sutures to ligaments of the pelvic floor
POP MEDICAL SOLUTIONS LTD
Ligament prosthesis| Primary Device ID | 07290017082004 |
| NIH Device Record Key | 7ad95d8f-1630-4f2c-8e47-85c930793729 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuGuide™ |
| Version Model Number | FG0001 |
| Catalog Number | FG0001 |
| Company DUNS | 600628181 |
| Company Name | POP MEDICAL SOLUTIONS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| 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 | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com | |
| Phone | +97237684948 |
| info@pop-medical.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away From Sunlight |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017082004 [Primary] |
| GS1 | 07290017082011 [Package] Package: Master [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160569
FDA Product Code
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-20 |
Trademark Results [NeuGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUGUIDE 86132159 4564061 Live/Registered |
FEMSELECT LTD. 2013-12-01 |
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