AccessGUDID - DEVICE: Aveta Tissue Catch with Suction Tubing (00850006759101)

GUDID

Device Identifier (DI) Information

Brand Name: Aveta Tissue Catch with Suction Tubing
Version or Model: 205-116
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 205-116
Company Name: MEDITRINA, INC.

Primary DI Number: 00850006759101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080570262 *Terms of Use

Device Description: Aveta Tissue Catch with Suction Tubing for use with Aveta System

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?
63210	Tissue morcellation system tissue preservation container	A non-sterile, non-powered component of a tissue morcellation system intended to house the system’s tissue filter assembly, to preserve collected tissues prior to histological/pathological analysis. It is a dedicated container designed to be filled with ice, and intended to integrate along the system’s suction line between the system’s handpiece and suction canister. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIG	Insufflator, Hysteroscopic
HIH	Hysteroscope (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190372	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: c72871a4-43f4-4981-99b8-4495a2411777
Public Version Date: December 06, 2019
Public Version Number: 1
DI Record Publish Date: November 28, 2019