AccessGUDID - DEVICE: Mammotome revolve (00841911100829)

GUDID

Device Identifier (DI) Information

Brand Name: Mammotome revolve
Version or Model: MHUS10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MHUS10
Company Name: DEVICOR MEDICAL PRODUCTS, INC.

Primary DI Number: 00841911100829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961832156 *Terms of Use

Device Description: Ultrasound Probe - CE

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?
58990	Side-notch biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. 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 [?]
K152989	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 10 Gauge

Device Record Status

Public Device Record Key: 6158a0cb-d09a-4fad-be8e-903b4ae9cd64
Public Version Date: August 30, 2024
Public Version Number: 5
DI Record Publish Date: October 24, 2016