AccessGUDID - DEVICE: Cellient® (15420045508576)

GUDID

Device Identifier (DI) Information

Brand Name: Cellient®
Version or Model: Cellient Finishing Station
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71664-001
Company Name: Hologic, Inc.

Primary DI Number: 15420045508576
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: Finishing station for use in embedding the Cellient® cell block in pariffin.

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?
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
IDT	APPARATUS, MELTING POINT, PARAFFIN

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
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -28 and 50 Degrees Celsius
Handling Environment Temperature: between 16 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd976f49-9a8c-49e9-9006-8f2a3d636157
Public Version Date: August 19, 2024
Public Version Number: 5
DI Record Publish Date: October 12, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)442-9892
Email: CustomerSupport@hologic.com

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