AccessGUDID - DEVICE: Flight Dental Systems (D884F411CA1)

GUDID

Device Identifier (DI) Information

Brand Name: Flight Dental Systems
Version or Model: F-411CA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flight Dental Systems

Primary DI Number: D884F411CA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 241275150 *Terms of Use

Device Description: Flight 1:1 Contra Angle, No Water Spray, Latch Head Push Button, One Piece Handpiece

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):	No
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
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181691	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d5a872c-a9a8-413a-9337-4c6b0bacb717
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024