AccessGUDID - DEVICE: ADVIA® Autoslide Methanol (00630414503943)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Autoslide Methanol
Version or Model: 10327567
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8096412
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414503943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: No description.

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):	No
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?
57724	Reagent grade alcohol solution IVD	A reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	SLIDE STAINER, AUTOMATED

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Flammable

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b20314f-d2e0-469f-984d-70e42145192a
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020