FDA.reportPublic FDA data

SourceMark

Primary DI
10813799003582
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
SLMIL10
Published
2020-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813799003582PackageGS110In Commercial Distribution
00813799003578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900358210813799003582
00813799003578008137990035788137990035780813799003578

GMDN Terms#

Term, Definition table
TermDefinition
Flexible fibreoptic 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 through a fibreoptic bundle to the user for direct visualization (i.e., non-video). 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
121225812
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830597Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830603Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830610Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830627Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830634Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830641Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830658Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830665Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830672Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830689Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830696Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830702Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830719Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830726Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831235Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831242Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831259Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831266Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831273Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831280Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831310Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30