AccessGUDID - DEVICE: MICRO PLASTIC SURGERY OSTEOTOME (00192896042896)

GUDID

Device Identifier (DI) Information

Brand Name: MICRO PLASTIC SURGERY OSTEOTOME
Version or Model: 475-785A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 475-785A
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896042896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: MICRO PLASTIC SURGERY OSTEOTOME WITHOUT GUARDS STRAIGHT TIPS

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?
12846	Plastic surgery osteotome	A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWM	OSTEOTOME

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.5 Millimeter Tip
Length: 8 Inch

Device Record Status

Public Device Record Key: 19be19ee-ca21-4181-afdd-c34b96597fad
Public Version Date: May 02, 2019
Public Version Number: 3
DI Record Publish Date: September 12, 2018