AccessGUDID - DEVICE: Aveta Disposable Resecting Handset (00850006759279)

GUDID

Device Identifier (DI) Information

Brand Name: Aveta Disposable Resecting Handset
Version or Model: 213-060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213-060
Company Name: MEDITRINA, INC.

Primary DI Number: 00850006759279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080570262 *Terms of Use

Device Description: Aveta Disposable Resecting Handset 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?
46730	Tissue morcellation system control unit	A mains electricity (AC-powered) component of a tissue morcellation system used to power and regulate the system's handpiece blade via cable connection; some designs may also provide suction intended for removal of resected tissue. This device will typically have hand and/or foot controls.	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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 8c3be62b-8de0-4311-8604-f60936813ba2
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 2020