AccessGUDID - DEVICE: HOUSE CUTOFF ADAPTER (B099412738500)

GUDID

Device Identifier (DI) Information

Brand Name: HOUSE CUTOFF ADAPTER
Version or Model: 412-738-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B099412738500
Issuing Agency: HIBCC
Commercial Distribution End Date: September 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HOUSE CUTOFF ADAPTER

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?
47845	Surgical power tool adaptor	A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

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 [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch

Device Record Status

Public Device Record Key: 451a32b2-f2e7-433b-ac8b-f2075ea26c09
Public Version Date: September 21, 2018
Public Version Number: 6
DI Record Publish Date: August 19, 2016