AccessGUDID - DEVICE: WELLENSCHLIFF NASAL SAW (00192896078291)

GUDID

Device Identifier (DI) Information

Brand Name: WELLENSCHLIFF NASAL SAW
Version or Model: 345-249
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 345-249
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896078291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: WELLENSCHLIFF NASAL SAW STRAIGHT TIP ROUND END

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?
42900	Nasal saw	A hand-held manual surgical instrument designed for cutting bone and/or cartilage in the nose. It is typically a one-piece metal instrument made of high-grade surgical steel with a handle at the proximal end and a long, thin, serrated blade at the distal end with the cutting teeth set in a straight line, a rounded nose at the tip, and a smooth edge on the top side of the blade to protect tissue not intended to be cut. The instrument is typically used in plastic (i.e., rhinoplasty) and reconstructive procedures of the nose. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBC	Saw, Nasal

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: 7.5 Inch

Device Record Status

Public Device Record Key: 2e9e2cb0-4b05-495a-90b7-e2b1a6b85a98
Public Version Date: August 01, 2023
Public Version Number: 2
DI Record Publish Date: September 21, 2018