FDA.reportPublic FDA data

DawnMist

Primary DI
20665973012869
Brand
DawnMist
Company
Dukal LLC
Model
PR01
Catalog number
PR01
Device description
Prep Razor Blue Hndl Plast Grd
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
20665973012869PackageGS110In Commercial Distribution
10665973012862PrimaryGS10
00665973012865Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2066597301286920665973012869
1066597301286210665973012862
00665973012865006659730128656659730128650665973012865

GMDN Terms#

Term, Definition table
TermDefinition
Safety razor, single-useA hand-held device fitted with an integral razor blade used to remove facial or body hair from a person or patient. It is known as a safety razor because the blade lies protected within the razor head leaving only the cutting edge exposed. This device can be used for skin preparation prior to treatment/surgical intervention or for normal grooming. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973027248Dukal27607276072022-12-06
20665973026675Dukal60409604092022-12-06
00665973027456Dukal700710470071042022-12-06
10665973032631Dukal550055002026-01-12
10665973032648Dukal550155012026-01-12
10665973032655Dukal550255022026-01-12
10665973032662Dukal550355032026-01-12
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
10665973033027Dukal553055302026-02-26
20665973033024Dukal553055302026-02-26
10665973018154American White Cross7665033 and 76900007665033 and 76900002022-12-07
10665973018178American White Cross767503376750332022-12-06
00665973022611Dukal985198512022-12-06
10665973020911Dukal11130111302026-01-30
10665973020935Dukal11127111272026-01-30
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30

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