AccessGUDID - DEVICE: Lares Research (D950105360)

GUDID

Device Identifier (DI) Information

Brand Name: Lares Research
Version or Model: LSPD VT 4:1 CNTRA ANGL W/O HEAD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10536
Company Name: LARES RESEARCH

Primary DI Number: D950105360
Issuing Agency: HIBCC
Commercial Distribution End Date: October 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 009127838 *Terms of Use

Device Description: Accessory, Low-Speed Attachment, ValueTorque, 4:1 Contra Angle

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":	No
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?
66244	Dental surgical power tool motorized handpiece/set, pneumatic	A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070001	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: No special storage conditions

Clinically Relevant Size

[?]

Size Type Text
Length: 5 Inch

Device Record Status

Public Device Record Key: 9fc45e82-ebee-4eed-8598-26b0d1564d81
Public Version Date: October 16, 2024
Public Version Number: 2
DI Record Publish Date: October 30, 2020