AccessGUDID - DEVICE: Temno (10885403089572)

GUDID

Device Identifier (DI) Information

Brand Name: Temno
Version or Model: FRA2020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FRA2020
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403089572
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: TEMNO FRANSEEN NEEDLE 20G X 20CM 10/CS

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?
61530	Cell-block cytology aspiration needle	A sterile, sharp bevel-edged, hollow tubular metal instrument, combined with a Luer connector containing an absorbent foam pad, intended to be used for the collection of a biopsy specimen by fine needle aspiration (FNA) and to enable cells in a fluid specimen to be incorporated into a cell block; it is not dedicated to a particular part of the anatomy. Cells from the aspirate are captured in the foam pad enabling processing and analysis of the specimen using techniques typically applied to solid tissue specimens (e.g., paraffin processing, histological sectioning, immunohistochemistry, in situ hybridization). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	INSTRUMENT, BIOPSY

FDA Premarket Submission

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

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
Length: 20 Centimeter
Needle Gauge: 20 Gauge

Device Record Status

Public Device Record Key: 79af086c-b20e-4a2d-802b-64b7e265ecff
Public Version Date: August 31, 2023
Public Version Number: 5
DI Record Publish Date: September 15, 2017