AccessGUDID - DEVICE: CUSTOMED (M20890010918160)

GUDID

Device Identifier (DI) Information

Brand Name: CUSTOMED
Version or Model: 712057839816
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9001091816
Company Name: CUSTOMED INC

Primary DI Number: M20890010918160
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627572217 *Terms of Use

Device Description: CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 160MM, PINK

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?
47540	Soft-tissue biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.	Obsolete	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: 160 Millimeter
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: 583a16b3-8c1d-4fdc-b9c6-cd5f6ec786b1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016