AccessGUDID - DEVICE: Biopsy Forceps (00816207020747)

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Forceps
Version or Model: SG-211-615
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SG-211-615
Company Name: ENDO-THERAPEUTICS, INC.

Primary DI Number: 00816207020747
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 825239189 *Terms of Use

Device Description: Endoscopic Biopsy Forceps with Needle

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: No 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
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Min channel 2.8 mm
Outer Diameter: 2.4 Millimeter
Length: 160 Centimeter

Device Record Status

Public Device Record Key: 4d12a9ef-39ea-4ddb-ae12-083088367073
Public Version Date: November 05, 2019
Public Version Number: 2
DI Record Publish Date: May 14, 2018