AccessGUDID - DEVICE: MPM Medical Supply (Private Label) (00859013006024)

GUDID

Device Identifier (DI) Information

Brand Name: MPM Medical Supply (Private Label)
Version or Model: KOP2005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KOP2005
Company Name: MANAN MEDICAL PRODUCTS, INC.

Primary DI Number: 00859013006024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831737957 *Terms of Use

Device Description: 20 GA X 5 CM Breast Localization Needle With Two Wires

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?
36190	Mammographic stereotactic biopsy system	An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAA	Needle, Aspiration And Injection, Disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K863848	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
Length: 5 Centimeter

Device Record Status

Public Device Record Key: 4356607a-2b3e-4964-8001-076416e3d261
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 12, 2017