AccessGUDID - DEVICE: Centra (00724995180621)

GUDID

Device Identifier (DI) Information

Brand Name: Centra
Version or Model: 00711247
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711247
Company Name: US Endoscopy

Primary DI Number: 00724995180621
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The Centra biopsy forceps is used to enter human gastrointestinal tract via flexible endoscope to obtain tissue sample in order to understand disease pathology.

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
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.1 Millimeter
Length: 2300 Millimeter

Device Record Status

Public Device Record Key: 4bec1d31-f9fd-4085-a021-d50e4af63767
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021