DEVICE: Key Surgical K-Wire and Pin Covers (00849771004196)

Device Identifier (DI) Information

Key Surgical K-Wire and Pin Covers
C-035
Not in Commercial Distribution
C035
KEY SURGICAL, INC.
00849771004196
GS1
March 21, 2024
2
604056226 *Terms of Use
K-Wire Covers, Sterile, Blue, .035-inch, 0.9mm, 2 per package
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
63247 Surgical instrument guard, single-use
A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use 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

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
Lumen/Inner Diameter: .035 Inch
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Device Record Status

48224cea-459f-4b57-bb53-e976ca30619d
March 25, 2024
4
December 09, 2020
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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
10849771004193 12 00849771004196 2024-03-21 Not in Commercial Distribution Box
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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: 00849771043584 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)541-7995
regulatory@keysurgical.com
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