AccessGUDID - DEVICE: Hexagonal Basket, Medium (00816207020488)

GUDID

Device Identifier (DI) Information

Brand Name: Hexagonal Basket, Medium
Version or Model: BGH-1615M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BGH-1615M
Company Name: ENDO-THERAPEUTICS, INC.

Primary DI Number: 00816207020488
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 retrieval device

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?
46454	Gastrointestinal/airway foreign body retrieval basket, single-use	A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K800970	000

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: Basket Size Hexagonal 22 mm
Device Size Text, specify: Min Channel 2.8 mm
Outer Diameter: 2.4 Millimeter
Length: 150 Centimeter

Device Record Status

Public Device Record Key: 3a471c37-2c7d-4047-b3d7-84f17787e683
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: September 20, 2016