Mendit Retriever Set ES0155

GUDID 07290019174042

The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to.

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 ID07290019174042
NIH Device Record Key4c539612-1726-49c4-b5ba-b4fa71933229
Commercial Distribution StatusIn Commercial Distribution
Brand NameMendit Retriever Set
Version Model NumberMendit Retriever set - Non-Resorbable suture
Catalog NumberES0155
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
GS107290019174042 [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 Retriever Set]

07290019174417The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the
07290019174042The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the
07290019174202Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional
07290019174196Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optiona
07290019174189Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optiona
07290019174172Retriever Cartridge is available in addition to the Applicator Cartridge and its use is optional

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