FDA.reportPublic FDA data

Mendit Applicator Set

Primary DI
07290019174127
Brand
Mendit Applicator Set
Company
ESCALA MEDICAL LTD
Model
Mendit Applicator Set -permanent suture (ePTFE USP
Catalog number
ES0515
Device description
The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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
K213783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213783000ApyxEscala Medical2022-04-05PBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019174127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019174127072900191741277290019174127

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, bioabsorbableA bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600469711
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019174219Mendit Single Applicator SetMendit Single Applicator Set - Resorbable suture ES06552026-03-10
07290019174226Mendit Single Applicator SetMendit Single Applicator Set - Permanent suture ES06562026-03-10
07290019174233Mendit Single Applicator SetMendit Single Applicator Set - permanent suture ES06572026-03-10
07290019174240Mendit Single Applicator SetMendit Single Applicator Set - permanent suture (ES06582026-03-10
07290019174257Mendit Retriver Universal SetMendit Retriver Universal SetES06482026-03-10
07290019174431Mendit Single Applicator SetMendit Single Applicator Set - Resorbable suture ES06472026-03-10
07290019174448Mendit Single Applicator SetMendit Single Applicator Set -- permanent suture (ES06542026-03-10
07290019174455Mendit securement element setMendit securement element setES06212026-03-10
07290019174103Mendit Reload SetMendit Reload Set - Permanent Suture (ePTFE 2-0)ES05112024-06-05
07290019174110Mendit Reload SetMendit Reload Set – Permanent Suture (ePTFE USP 0ES05162024-06-05
07290019174141Mendit Reload SetMendit Reload Set – Permanent Suture (Prolene USPES05242024-06-05
07290019174165Mendit Reload SetMendit Reload Set – Resorbable Suture (PDS USP 0)ES05292024-06-05
07290019174059Mendit Reload SetMendit Reload Set – Permanent Suture (Prolene USP ES03222023-10-23
07290019174424Mendit Reload SetMendit Reload Set – Resorbable Suture (PDS USP 2-0ES01722023-10-23
07290019174028Mendit Reload SetMendit Reload Set – Resorbable Suture ES03212023-06-25
07290019174097Mendit applicator set Mendit applicator set - permanent suture (ePTFE 2-ES05102024-06-05
07290019174134Mendit Applicator SetMendit Applicator Set - permanent suture (Prolene ES05232024-06-05
07290019174158Mendit Applicator SetMendit Applicator Set - Resorbable suture (PDS USPES05282024-06-05
07290019174172Mendit Retriever SetMendit Retriever Set - Resorbable suture (PDS USP ES05302024-06-05
07290019174189Mendit Retriever SetMendit Retriever Set - permanent suture (Prolene UES05252024-06-05

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
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
07290019174066APYX Applicator SetESCALA MEDICAL LTDPBQ2022-11-03