Mendit Applicator Set ES0154

GUDID 07290019174035

The Mendit is a single use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit device comprises the following elements: Applicator – a delivery system comprising Applicator Cartridge and Handle, an Anchor-Suture unit (pre-loaded in the Applicator Cartridge), a Securement Element for optional use and Retriever – an accessory tool comprising of Retriever Cartridge and Handle. The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.

ESCALA MEDICAL LTD

Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable
Primary Device ID07290019174035
NIH Device Record Key4d0fdde8-8cfb-43ef-868a-a00536c7d5a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMendit Applicator Set
Version Model NumberMendit Applicator Set - Non-Resorbable suture
Catalog NumberES0154
Company DUNS600469711
Company NameESCALA MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Handling Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019174035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-31
Device Publish Date2023-10-23

On-Brand Devices [Mendit Applicator Set]

07290019174035The Mendit is a single use repair system which enables anchoring of sutures to ligaments of the
07290019174158The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to
07290019174134The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to
07290019174127The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to
07290019174097The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to
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