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 Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer Ligament graft, synthetic polymer| 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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