AccessGUDID - DEVICE: MICTEC MAGNET NEEDLE CATCHER (00192896007994)

GUDID

Device Identifier (DI) Information

Brand Name: MICTEC MAGNET NEEDLE CATCHER
Version or Model: 20918-80
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896007994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use
Previous DI: B09920918800

Device Description: MICTEC MAGNET NEEDLE CATCHER

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?
62044	Sharp surgical instrument retrieval magnet	A non-sterile, magnetic device intended to be used primarily within an operating room (OR) to pick up metallic instruments/devices (e.g., needles, blades) that have been dropped/mislaid on the floor. It is a non-powered device that includes a fixed magnetic rod/axle with wheels connected to long handle, whereby small, typically sharp, metallic instruments are picked up by magnetism. 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
Device Size Text, specify: 5.0mm Diameter
Length: 300 Millimeter

Device Record Status

Public Device Record Key: 8ee20a3f-bb34-4672-b85f-62e342d27b87
Public Version Date: September 24, 2018
Public Version Number: 1
DI Record Publish Date: August 23, 2018