AccessGUDID - DEVICE: CUFF:INFLATION FOR ROSI (00817122020430)

GUDID

Device Identifier (DI) Information

Brand Name: CUFF:INFLATION FOR ROSI
Version or Model: 200812
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200812
Company Name: VASCULAR TECHNOLOGY, INCORPORATED

Primary DI Number: 00817122020430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 161989343 *Terms of Use

Device Description: Part Number 200812, CUFF:INFLATION FOR ROSI

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?
33579	Surgical irrigation/aspiration pump, reusable	An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141323	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 41fd5599-68ac-4cae-9998-120c52ef7c4f
Public Version Date: February 08, 2024
Public Version Number: 4
DI Record Publish Date: September 20, 2016