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.
C-035
Not in Commercial Distribution
C035
KEY SURGICAL, INC.
K-Wire Covers, Sterile, Blue, .035-inch, 0.9mm, 2 per package
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | Orthopedic Manual Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: .035 Inch |
Device Record Status
48224cea-459f-4b57-bb53-e976ca30619d
March 25, 2024
4
December 09, 2020
March 25, 2024
4
December 09, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00849771043584
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)541-7995
regulatory@keysurgical.com
regulatory@keysurgical.com