AccessGUDID - DEVICE: Nezhat-Dorsey (00801741065385)

GUDID

Device Identifier (DI) Information

Brand Name: Nezhat-Dorsey
Version or Model: 5102710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5102710
Company Name: Davol Inc.

Primary DI Number: 00801741065385
Issuing Agency: GS1
Commercial Distribution End Date: February 17, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: Nezhat-Dorsey Trumpet Valve, with 5mmx33cm Probe Tip, and Suction Tubing (Series 4)

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":	No
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?
64119	Surgical irrigation/aspiration cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 33 Centimeter

Device Record Status

Public Device Record Key: 8649bde2-f68b-4530-bd4a-2b3315f91525
Public Version Date: October 22, 2024
Public Version Number: 4
DI Record Publish Date: December 23, 2015