AccessGUDID - DEVICE: CUSA® Clarity (10381780536352)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Clarity
Version or Model: C7421SEA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7421SEA
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780536352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
LBK	Neurosurgical ultrasonic instruments
LFL	Instrument, ultrasonic surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221835	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47e88327-f077-4080-8f81-643463a04706
Public Version Date: November 23, 2022
Public Version Number: 1
DI Record Publish Date: November 15, 2022