AccessGUDID - DEVICE: MICASEPT BIOPSY AND GRASPING FORCEPS (00192896008526)

GUDID

Device Identifier (DI) Information

Brand Name: MICASEPT BIOPSY AND GRASPING FORCEPS
Version or Model: 20920-06-004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20920-06-004
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896008526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use
Previous DI: B09920920060040

Device Description: MICASEPT BIOPSY AND GRASPING FORCEPS WITH 2 FANGS WITH HEGAR RATCHET

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?
35732	Rigid endoscopic biopsy forceps, reusable	A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. 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: 4.5mm Diameter
Length: 300 Millimeter

Device Record Status

Public Device Record Key: fa374e6d-3852-4b80-8535-eee6e146a1e7
Public Version Date: September 26, 2024
Public Version Number: 3
DI Record Publish Date: August 23, 2018