AccessGUDID - DEVICE: OptiBite Disposable Biopsy Forceps (06932503540384)

GUDID

Device Identifier (DI) Information

Brand Name: OptiBite Disposable Biopsy Forceps
Version or Model: 100578
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100578
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503540384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Normal handle, Oval, without spike, Single outer sheath, FEP coated, Two Wire, 2.3*2300 mm

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:	Yes
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?
46228	Rigid endoscopic biopsy forceps, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCL	Forceps, Biopsy, Non-Electric

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 230 Centimeter
Lumen/Inner Diameter: 2.8 Millimeter

Device Record Status

Public Device Record Key: 26a30014-c5eb-420c-953d-3f9663b90ddb
Public Version Date: October 10, 2024
Public Version Number: 3
DI Record Publish Date: March 23, 2020