FDA.reportPublic FDA data

SourceMark

Primary DI
00813799003752
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
CV3BL
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813799003766PackageGS120In Commercial Distribution
20813799003770PackageGS15In Commercial Distribution
00813799003752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900376610813799003766
2081379900377020813799003770
00813799003752008137990037528137990037520813799003752

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video laryngoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.

Regulatory Flags#

DUNS number
121225812
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813799000003SourceMark M09062020-07-07
00813799000034SourceMark M09082020-07-07
00813799000065SourceMark M09102020-07-07
00813799000096SourceMark M0912 2020-07-07
00813799000126SourceMark M09142020-07-07
00813799007354SourceMark M09062020-11-06
00813799007385SourceMark M09082020-11-06
00813799007415SourceMark M09102020-11-06
00813799007446SourceMark M09122020-11-06
00813799007477SourceMark M09142020-11-06
00897392001322SourceMark M09142016-08-26
00897392001339SourceMark M09102016-08-26
00897392001346SourceMark M09062016-08-26
00813799005084SourceMark M1205 2020-07-09
00813799002748SourceMark CV3WF2022-02-24
00813799002861SourceMark CV1002022-02-24
00813799002878SourceMark CVST12022-02-24
08973920006501KozeeM210012020-01-27
08973920006518KozeeM210022020-01-27
08973920006525KozeeM210032020-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407721749FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721756FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721770FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721787FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721794FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721831FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721862FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721879FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721916FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721923FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722036FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722043FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722050FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722067FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722388FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722395FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722401FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722418FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722425FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722432FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722456FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722463FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722470FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722487FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722494FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722500FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722517FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722524FENTEXFENTEX medical GmbHLRC2022-12-09