DEVICE: COUGAR (10705034361123)

Device Identifier (DI) Information

COUGAR
292955621
In Commercial Distribution
292955621
DEPUY SPINE, LLC
10705034361123
GS1

1
107105876 *Terms of Use
COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED PITUITARY, RIGHT 6mm
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic rongeur A hand-held manual surgical instrument with a cutting/biting action designed to remove bone during an orthopaedic intervention. It is a heavy-duty instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HTX RONGEUR
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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

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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

08221319-a1cd-4264-b69f-3ba05182c92c
March 29, 2018
2
December 31, 2016
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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