AccessGUDID - DEVICE: MICTEC PLEURA ABRADER (B09920942500)

GUDID

Device Identifier (DI) Information

Brand Name: MICTEC PLEURA ABRADER
Version or Model: 20942-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09920942500
Issuing Agency: HIBCC
Commercial Distribution End Date: September 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: MICTEC PLEURA ABRADER BALL STYLE ANGLED DOWN

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?
35345	Lung spatula	A hand-held manual surgical instrument designed to manipulate the pulmonary tissue/surfaces of the lungs during a surgical intervention in the thorax. It typically consists of a large flat blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of stainless steel and is available with a variety of blade designs, e.g., curved and flat with a protected rounded end, a wire basket structure of interconnected round wires, or broad and flat with fenestrations. The blade and handle can be designed to be at various ergonomic angles to each other. This instrument is sometimes referred to as a lung retractor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	000

Device Exempt from Premarket Submission: No 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
Length: 300 Millimeter

Device Record Status

Public Device Record Key: dec5e8b0-b59c-4bc2-ab03-5d9f15422ea1
Public Version Date: September 28, 2018
Public Version Number: 5
DI Record Publish Date: September 30, 2016