AccessGUDID - DEVICE: Leica TP1020 with Chloroform (04049188087706)

GUDID

Device Identifier (DI) Information

Brand Name: Leica TP1020 with Chloroform
Version or Model: 000000014042242238
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14042242238
Company Name: Leica Biosystems Nussloch GmbH

Primary DI Number: 04049188087706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315539452 *Terms of Use

Device Description: The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU

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):	Yes
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?
57859	Tissue processor IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IEO	PROCESSOR, TISSUE, 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:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 77cc59a9-87be-4c13-b6ce-f6eb4e977e00
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: November 16, 2018