AccessGUDID - DEVICE: PARALLEL WIRE EXTRACTION PLIERS (00192896051546)

GUDID

Device Identifier (DI) Information

Brand Name: PARALLEL WIRE EXTRACTION PLIERS
Version or Model: 1103-125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1103-125
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896051546
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN CARBIDE CUTTER

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?
38830	Wire-extracting pliers	A manual surgical instrument specially designed to grip the end of a wire, typically the self-boring type, for its extraction from the patient's body. It has a scissors-like design with strong curved handles and short pointed jaws that are heavily serrated to grip the end of the wire for extraction. It is made of high-grade stainless steel and some types can have a threaded screw that the surgeon tightens which increases the pressure (the grip) on the jaws. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXZ	CUTTER, WIRE

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: For Wires up to 1.6 Millimeters in Diameter
Length: 4.5 Inch

Device Record Status

Public Device Record Key: c80299f0-b52f-4061-81ec-a55e1d78d657
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2018