AccessGUDID - DEVICE: CUSTOMED (M20890017020200)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: 712057832020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9001702020
Company Name: CUSTOMED INC

Primary DI Number: M20890017020200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: CUSTOMED CHIBA BIOPSY FINE ASPIRATION NEEDLE, 20G X 200MM, YELLOW

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 [?]
K092338	000

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
Special Storage Condition, Specify: Sterile if package is unopened or undamaged.
Special Storage Condition, Specify: Keep in a cool, dry place, away from heat and light sources.

Clinically Relevant Size

[?]

Size Type Text
Length: 200 Millimeter
Needle Gauge: 20 Gauge

Device Record Status

Public Device Record Key: fb727c5f-8be8-417b-8877-03033820e1a5
Public Version Date: July 12, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M20890017020201	20	M20890017020200		In Commercial Distribution	20/BOX

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 787-622-5151
Email: customer.service@customedhealing.com

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