DEVICE: CUSA® Clarity (10381780536352)

Device Identifier (DI) Information

CUSA® Clarity
C7421SEA
In Commercial Distribution
C7421SEA
INTEGRA LIFESCIENCES (IRELAND) LIMITED
10381780536352
GS1

1
989925396 *Terms of Use
CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack)
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
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?
60718 Hard-tissue ultrasonic surgical system handpiece tip
A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LBK Neurosurgical ultrasonic instruments
LFL Instrument, ultrasonic surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K221835 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep Dry; Do not use if package is damaged
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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

47e88327-f077-4080-8f81-643463a04706
November 23, 2022
1
November 15, 2022
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
+1(800)654-2873
custsvcnj@integralife.com
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