FDA.reportPublic FDA data

Mendit applicator set

Primary DI
07290019174097
Brand
Mendit applicator set
Company
ESCALA MEDICAL LTD
Model
Mendit applicator set - permanent suture (ePTFE 2-
Catalog number
ES0510
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
07290019174097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019174097072900191740977290019174097

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
07290019174127Mendit Applicator SetMendit Applicator Set -permanent suture (ePTFE USPES05152024-06-05
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
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
07290019174066APYX Applicator SetESCALA MEDICAL LTDPBQ2022-11-03