AccessGUDID - DEVICE: Remington Medical, Inc. Automatic Cutting Needle (NAC) (00813079022343)

GUDID

Device Identifier (DI) Information

Brand Name: Remington Medical, Inc. Automatic Cutting Needle (NAC)
Version or Model: NAC-2010 ULTRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NAC-2010 ULTRA
Company Name: REMINGTON MEDICAL, INC.

Primary DI Number: 00813079022343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788472314 *Terms of Use

Device Description: Automatic Cutting Needles (NAC-Ultra) 20 ga x 10 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
64327	End-cut biopsy gun needle	An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. 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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Centimeter

Device Record Status

Public Device Record Key: 7a3683b7-b0e6-4829-82de-986cdb004236
Public Version Date: January 27, 2025
Public Version Number: 1
DI Record Publish Date: January 17, 2025