AccessGUDID - DEVICE: Vilex Power Accessory (00841731118394)

GUDID

Device Identifier (DI) Information

Brand Name: Vilex Power Accessory
Version or Model: BO1035FN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BO1035FN
Company Name: VILEX IN TENNESSEE, INC.

Primary DI Number: 00841731118394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152008371 *Terms of Use

Device Description: Blade, Osc. 10.0x35mm Fine

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:	Yes
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?
46476	Surgical saw blade, oscillating, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFA	Blade, Saw, General & Plastic Surgery, Surgical

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: 49efa6bc-798f-43df-890c-0c517b50dca1
Public Version Date: January 22, 2021
Public Version Number: 4
DI Record Publish Date: September 18, 2018