DEVICE: Intro (08052440106363)

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Device Record History
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Device Identifier (DI) Information
Intro
PT1705
Not in Commercial Distribution
PT1705
M.D.L. S.R.L.
08052440106363
GS1
May 14, 2021
1
447228586 *Terms of Use
COAXIAL INTRODUCER NEEDLE 17G X 50mm
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Device Characteristics
MR Unsafe
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?
62257 Orthopaedic coaxial injection applicator
A tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MJG Device, Percutaneous, Biopsy
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 17 Gauge
Length: 50 Millimeter
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Device Record Status
ff85097e-c668-451e-ae8d-885b84152c56
May 27, 2021
9
March 14, 2017
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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
08058341216682 10 08052440106363 2021-05-14 Not in Commercial Distribution
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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