DEVICE: Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm (B90823991238)

Device Identifier (DI) Information

Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
239-91-238
In Commercial Distribution
IFLX-DFS-6mm
Mainstream Medical Devices, LLC
B90823991238
HIBCC

1
071513432 *Terms of Use
Isto Disposable Funnel System Shooter 6mm Cannula, Pusher 5.5mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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No
No

GMDN

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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?
62546 Intraoperative orthopaedic bone pin/screw, single-use
A small rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) and/or implantable device (e.g., fixation plate) to the bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments/devices. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
GEA Cannula, Surgical, General & Plastic Surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

73d0e074-0c09-42eb-ab1f-484ab012ffed
July 28, 2023
1
July 20, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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