FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuGuide™
DI: 07290017082004
·
Model: FG0001
·
FEMSELECT LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NeuGuide™
- Primary DI
- 07290017082004
- Version / Model
- FG0001
- Catalog Number
- FG0001
- Company Name
- FEMSELECT LTD
- Labeler DUNS
- 600628181
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-20
- Public Version
- 4
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 7ad95d8f-1630-4f2c-8e47-85c930793729
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47030 | Ligament graft, synthetic polymer | An implantable, non-bioabsorbable device made of synthetic polymer materials (e.g., polyester) intended to be used to replace a missing or damaged ligament to restore natural function. Some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto bone; disposable devices associated with implantation may be included. Also referred to as a ligament prosthesis, it is commonly used for ligament reconstruction in the knee [e.g., patellofemoral ligament, anterior cruciate ligament (ACL)] or shoulder (e.g., glenohumeral ligament) joints. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017082004 | GS1 | ||||
| Package | 07290017082011 | GS1 | Master | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- +97237684948
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160569 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius