DEVICE: TSI (00851797006191)

Device Identifier (DI) Information

TSI
ML-0440S
Not in Commercial Distribution

TEDAN SURGICAL INNOVATIONS, L.L.C.
00851797006191
GS1
March 18, 2020
1
791619393 *Terms of Use
XL INSULATED DILATORS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
47128 Lumbar interspinous decompression instrument set, single-use
A collection of sterile surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, and an implant holder. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
PDQ Neurosurgical Nerve Locator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140088 000
No 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
Width: 8 Millimeter
Width: 13 Millimeter
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Device Record Status

28054295-ad0f-40c9-bb77-c03adb222e14
March 19, 2020
4
October 14, 2016
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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
No Package DIs found
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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
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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