DEVICE: PIPELINE (10705034221083)

Device Identifier (DI) Information

PIPELINE
288226160
In Commercial Distribution
288226160
DEPUY SPINE, LLC
10705034221083
GS1

1
107105876 *Terms of Use
PIPELINE ACCESS SYSTEM ANGLED RETRACTION PORT 26 x 60mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Surgical retractor/retraction system blade, single-use A sterile component of a surgical retraction system or surgical retractor designed to function as a parting edge/hook to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GZT RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K992898 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

e8c587e5-0b4b-4c67-af0d-fb2877e37ca1
July 06, 2018
4
June 30, 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

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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
No
No CLOSE

Customer Contact

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