CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890022011100
• Version / Model: 712057831110
• Catalog Number: 9002201110
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fbaf12d2-f01b-4972-b0e1-588e41fce042

Device Description

CUSTOMED J-MAX DIAMOND TIP BIOPSY NEEDLE, 11G X 100MM, WHITE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20890022011100	HIBCC
Package	M20890022011101	HIBCC	10/BOX	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092338	000

Device Sizes

Type	Value	Unit	Text
Length	100	Millimeter
Needle Gauge	11	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Sterile if package is unopened or undamaged.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep in a cool, dry place, away from heat and light sources.