DEVICE: ENDCAP NON-IMPINGING (00887868032912)

Device Identifier (DI) Information

ENDCAP NON-IMPINGING
8007-00-001
In Commercial Distribution
800700001
Biomet Orthopedics, LLC
00887868032912
GS1

1
129278169 *Terms of Use
No description.
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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
Bone nail end-cap, sterile A small, sterile, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HSB ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003797 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

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

d1bb2f46-58e4-4edf-9ef3-c5c6f0a15b8e
October 22, 2018
4
October 24, 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

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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)348-9500
customerservice@zimmerbiomet.com
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