AccessGUDID - DEVICE: MPM Medical Supply (Private Label) (00859013006000)

GUDID

Device Identifier (DI) Information

Brand Name: MPM Medical Supply (Private Label)
Version or Model: BMNJ-MEC-1110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BMNJ-MEC-1110
Company Name: MANAN MEDICAL PRODUCTS, INC.

Primary DI Number: 00859013006000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831737957 *Terms of Use

Device Description: 11 GA X 4" Double Diamond J-Type Bone Needle With 14 GA Extraction Cannula

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?
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWO	Needle, Biopsy, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890925	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: 4 Inch

Device Record Status

Public Device Record Key: 8c4323ed-8699-4ece-b3b5-fc56c863c53e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 12, 2017