AccessGUDID - DEVICE: MT (46932503540047)

GUDID

Device Identifier (DI) Information

Brand Name: MT
Version or Model: NBF02-11118120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 46932503540047
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: New handle, Oval, with spike, Single outer sheath, FEP coated, Four-bar linkage, 1.8*1200 mm , 25 pcs in the box

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":	Yes
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?
38711	Flexible endoscopic biopsy forceps, single-use	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of 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
No Device Sizes

Device Record Status

Public Device Record Key: 0bd939e2-26d4-45ad-9cdd-0024a56b7e85
Public Version Date: August 22, 2024
Public Version Number: 2
DI Record Publish Date: December 31, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
56932503540044	25	46932503540047	2024-07-31	Not in Commercial Distribution	BOX
66932503540041	2	56932503540044	2024-07-31	Not in Commercial Distribution	CASE
76932503540048	4	66932503540041	2024-07-31	Not in Commercial Distribution	Transport CASE