AccessGUDID - DEVICE: V. Mueller (10885403426414)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: S-VAT-SG4700-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SVATSG47001
Company Name: STERIS CORPORATION

Primary DI Number: 10885403426414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller HUMAN TRIAL INST- NOT FOR SALE VATS MICT REGIONAL SET ORLANDO RGNL VATS TRAY 1 SET CONTAINS TWELVE COMPONENTS

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:	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?
46409	Cardiothoracic surgical procedure kit, non-medicated, reusable	A collection of various sterile cardiothoracic surgical instruments dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This device is reusable after appropriate cleaning/sterilization of the instruments/reusable products, and when the consumable/pharmaceutical products have been replenished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFA	Cardiovascular surgical instruments tray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: d0fbf814-bd89-4c3b-b398-3da7068e4c0b
Public Version Date: September 05, 2024
Public Version Number: 5
DI Record Publish Date: December 28, 2017