AccessGUDID - DEVICE: CUSA® Selector® (10381780040415)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Selector®
Version or Model: 1523072M3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780040415
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
47676	Ultrasonic surgical system torque wrench, single-use	A sterile hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021989	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ce30ea0-2e80-4007-b4eb-ec27c500c212
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 29, 2016