FDA.reportPublic FDA data

Oak Ridge Products

Primary DI
00852482006823
Brand
Oak Ridge Products
Company
OAKRIDGE PRODUCTS, LLC
Model
0701-5800
Device description
This Shave Prep Razor is a double sided razor made for the preparation of a patient. Color: BlackBody Length: 92.5 mmBody width: 44.0 mm
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10852482006820PackageGS1100In Commercial Distribution
00852482006823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085248200682010852482006820
00852482006823008524820068238524820068230852482006823

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

Regulatory Flags#

DUNS number
111322165
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
00852482006830Oak Ridge Products0105-01002023-09-20
10852482006837Oak Ridge Products0105-01002023-09-20
00852482006847Oak Ridge Products0401-11002023-09-20
00852482006410Oak Ridge Products0310-150T2016-09-22
00852482006502Oak Ridge Products0319-15002016-09-22
00852482006519Oak Ridge Products0319-150F2016-09-22
00852482006526Oak Ridge Products0330-15002016-09-22
00852482006533Oak Ridge Products0310-16002016-09-23
00852482006557Oak Ridge Products0330-150R2016-09-22
00852482006564Oak Ridge Products0320-150F2016-09-22
00852482006571Oak Ridge Products0311-150F2016-09-22
00852482006588Oak Ridge Products0319-150R2016-09-22
00852482006595Oak Ridge Products0320-150R2016-09-22
00865273000009Oak Ridge Products0322-150R2016-09-22
00865273000016Oak Ridge Products0310-15002016-09-22
00865273000023Oak Ridge Products0320-15002016-09-22
00865273000030Oak Ridge Products0354-150M2016-09-22
00865273000047Oak Ridge Products0354-150H2016-09-22
00865273000054Oak Ridge Products0354-150B2016-09-22
00865273000061Oak Ridge Products0354-110B2016-09-22

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