NeuGuide™

Primary DI
07290017082004
Brand
NeuGuide™
Company
FEMSELECT LTD
Model
FG0001
Catalog number
FG0001
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.
Published
2017-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic UseObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160569000NeuGuidePop Medical Solutions2016-07-06PBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017082011PackageGS13In Commercial Distribution
07290017082004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017082011072900170820117290017082011
07290017082004072900170820047290017082004

GMDN Terms#

Term, Definition table
TermDefinition
Ligament prosthesisA sterile, implantable, non-bioabsorbable device intended to be used as a direct ligament substitute to replace a missing or damaged ligament for restoring natural function. It is made of synthetic polymer materials (e.g., polyester), and some types may in addition include a metal anchoring component (e.g., staple, screw) for fixation onto the bone; disposable devices associated with implantation may be included. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97237684948info@pop-medical.com

Regulatory Flags#

DUNS number
600628181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017082056EnPlace Refill KitFG-0004-RFG-0004-R2026-01-08
07290017082028EnPlaceFG-00001-02FG-00001-022022-06-19
17290017082025EnPlaceFG-00001-02FG-00001-022022-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019174219Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174226Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174233Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174240Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174257Mendit Retriver Universal SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174431Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174448Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174455Mendit securement element setESCALA MEDICAL LTDPBQ2026-03-10
17290017082056EnPlace Refill KitFEMSELECT LTDPBQ2026-01-08
07290019174097Mendit applicator set ESCALA MEDICAL LTDPBQ2024-06-05
07290019174103Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174110Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174127Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174134Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174141Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174158Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174165Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174172Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174189Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174196Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174202Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174035Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174042Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174059Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174400Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174417Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174424Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174004APYX Applicator SetESCALA MEDICAL LTDPBQ2023-08-06
07290019174028Mendit Reload SetESCALA MEDICAL LTDPBQ2023-06-25
07290019174011APYX Retriever SetESCALA MEDICAL LTDPBQ2022-11-06