AccessGUDID - DEVICE: Automatic Cutting Needle (00813079020868)

GUDID

Device Identifier (DI) Information

Brand Name: Automatic Cutting Needle
Version or Model: NAC-1816B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NAC-1816B
Company Name: REMINGTON MEDICAL, INC.

Primary DI Number: 00813079020868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788472314 *Terms of Use

Device Description: 18 ga (1.3mm) x 16 cm

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?
57796	Prostate biopsy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a prostatic tissue specimen typically for histopathological examination. It is available in various diameters and has a distal tip that may be configured in various geometric forms. It is commonly used during a transrectal ultrasound (TRUS) scan. 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 [?]
K982401	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: cb4bd6c2-d0b6-498e-b143-cd3b69f787c8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016