DEVICE: endomina platform (05425029282018)

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Device Record History
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Device Identifier (DI) Information
endomina platform
endomina platform
In Commercial Distribution

Endo Tools Therapeutics
05425029282018
GS1

1
400000750 *Terms of Use
endomina platform primary packaging (x1)
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Device Characteristics
MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46687 Endoscopic overtube, single-use
A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OCW Endoscopic Tissue Approximation Device
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K211309 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 1 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a1ad52c8-daf2-450d-94bd-27e09cc8c4f7
October 28, 2024
4
July 19, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05425029282117 1 05425029282018 In Commercial Distribution secondary packaging
05425029282339 4 05425029282117 In Commercial Distribution Tertiary packaging
05425029282940 4 05425029282339 In Commercial Distribution Pallet
05425029282957 12 05425029282339 In Commercial Distribution Pallet
05425029282926 16 05425029282339 In Commercial Distribution Pallet
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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