DEVICE: PERPOS PLS Instruments with Tray (81195401009648)

Device Identifier (DI) Information

PERPOS PLS Instruments with Tray
9039-02
Not in Commercial Distribution
9039-02
INTERVENTIONAL SPINE, INC
81195401009648
GS1
December 23, 2016
1
017663522 *Terms of Use
Instrument kit contains quantity of 1 each: Perpos 2 in 1 Drill, Perpos K-Wire, Perpos Pull Pin Remover, Perpos Tap, Perpos Device Driver, Perpos Compression Tool, Tray Assembly
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
44054 Orthopaedic surgical procedure kit, non-medicated, reusable
A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXH Orthopedic Manual Surgical Instrument
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

6ac04de1-c89b-4fc2-ae8c-207400ae09fa
March 29, 2018
2
September 15, 2015
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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
No
No
No CLOSE

Customer Contact

[?]
800-497-0484
www.cs@i-spineinc.com
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