Durasphere ® 890-205

GUDID 00858015005615

Injection Needle, Spinal Tip

Carbon Medical Technologies, Inc.

Submucosal injection needle
Primary Device ID00858015005615
NIH Device Record Key5e9c53c4-9474-427a-91c4-1d67231b95fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurasphere ®
Version Model Number890-205
Catalog Number890-205
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8882070262
Emailinfo@carbonmed.com

Device Dimensions

Needle Gauge18 Gauge
Needle Gauge18 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100858015005615 [Primary]

FDA Product Code

FBKEndoscopic Injection Needle, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-19
Device Publish Date2016-10-12

On-Brand Devices [Durasphere ® ]

00858015005639Injection Needle, Pencil Point
00858015005622Injection Needle, Pencil Point
00858015005615Injection Needle, Spinal Tip
00858015005608Injection Needle, Spinal Tip

Trademark Results [Durasphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURASPHERE
DURASPHERE
87479253 not registered Dead/Abandoned
Kyocera International, Inc.
2017-06-07
DURASPHERE
DURASPHERE
75574354 2373853 Live/Registered
Advanced UroScience, Inc.
1998-10-21

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