AccessGUDID - DEVICE: Hobbs Helical Retrieval Basket Handle (M84948500)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Helical Retrieval Basket Handle
Version or Model: 4850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4850
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84948500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: A control handle for a flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. The device is constructed of a flexible metal coil and plastic tube whose distal end is equipped with a helical shaped basket which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable 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:	No
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?
35524	Flexible endoscopic tissue manipulation forceps, reusable	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable 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 [?]
K833124	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

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: 86e9cccd-200d-4f88-bb43-af8300f0ccd8
Public Version Date: June 12, 2023
Public Version Number: 4
DI Record Publish Date: September 21, 2016