FDA.reportPublic FDA data

EnPlace

Primary DI
17290017082025
Brand
EnPlace
Company
FEMSELECT LTD
Model
FG-00001-02
Catalog number
FG-00001-02
Published
2022-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
17290017082025PackageGS13In Commercial Distribution
07290017082028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001708202517290017082025
07290017082028072900170820287290017082028

GMDN Terms#

Term, Definition table
TermDefinition
Ligament graft, synthetic polymerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972549456260debbie@femselect.com
+1-215-940-8178debbie@femselect.com

Regulatory Flags#

DUNS number
600628181
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07290017082004NeuGuide™FG0001FG00012017-10-20

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