AccessGUDID - DEVICE: RFS Instrument (E302RFSCS459)

GUDID

Device Identifier (DI) Information

Brand Name: RFS Instrument
Version or Model: RFS-CS45
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RFS-CS45
Company Name: Bioretec Oy

Primary DI Number: E302RFSCS459
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 368715301 *Terms of Use

Device Description: RFS™ Countersink 4.5mm

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?
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 96948811-5e36-46f9-be31-c51cb646502f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016