FDA.reportPublic FDA data

SourceMark

Primary DI
10813799006712
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
SMBLADENF
Published
2020-07-21
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
LWKRazor, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWKRazor, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813799006712PackageGS150In Commercial Distribution
00813799006708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900671210813799006712
00813799006708008137990067088137990067080813799006708

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hair clippersA hand-held electrically-powered device designed for removing long hair from the head or body of a patient prior to surgery/treatment. The device is typically operated by a healthcare professional. 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
10885380213281CARDINAL HEALTHCardinal Health 200, LLCLWK2026-05-27
00197998192449Solventum™Solventum US LLCLWK2026-02-15
00197998192463Solventum™Solventum US LLCLWK2026-02-15
00197998192487Solventum™Solventum US LLCLWK2026-02-15
00197998192715Solventum™Solventum US LLCLWK2026-02-15
00197998192739Solventum™Solventum US LLCLWK2026-02-15
00197998192753Solventum™Solventum US LLCLWK2026-02-15
00197998276347Solventum™Solventum US LLCLWK2026-02-15
00197998315503Solventum™Solventum US LLCLWK2026-02-15
00197998315534Solventum™Solventum US LLCLWK2026-02-15
00197998192456Solventum™Solventum US LLCLWK2026-02-15
00197998192470Solventum™Solventum US LLCLWK2026-02-15
00197998192494Solventum™Solventum US LLCLWK2026-02-15
00197998192722Solventum™Solventum US LLCLWK2026-02-15
00197998192746Solventum™Solventum US LLCLWK2026-02-15
00197998192760Solventum™Solventum US LLCLWK2026-02-15
00197998276354Solventum™Solventum US LLCLWK2026-02-15
00197998315510Solventum™Solventum US LLCLWK2026-02-15
00197998315541Solventum™Solventum US LLCLWK2026-02-15
00661392011755LSL HEALTHCARELSL Industries, LLCLWK2025-10-30
107073878145783M™3M COMPANYLWK2025-03-28
507073878145763M™3M COMPANYLWK2025-03-28
00850063139328NEIL MEDICALNeil Medical GroupLWK2025-03-14
85006313932800NEIL MEDICALNeil Medical GroupLWK2025-03-14
107073878145853M™3M COMPANYLWK2024-08-19
107073878145923M™3M COMPANYLWK2024-08-19
107073878146083M™3M COMPANYLWK2024-08-19
107073878146153M™3M COMPANYLWK2024-08-19
507073878145833M™3M COMPANYLWK2024-08-19
507073878145903M™3M COMPANYLWK2024-08-19