FDA.report

ASP MEDICAL

Primary DI
00840216100121
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
RZT102
Device description
DISPOSABLE RAZOR, WITH TWIN BLADE
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LWKRazor, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LWKRazor, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216100121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216100121008402161001218402161001210840216100121

GMDN Terms

TermDefinition
Razor bladeA device with an extremely sharp cutting edge intended to be inserted into a reusable razor to enable hair removal. It comes in various designs, traditionally with two cutting edges (one on either side of the blade's width). Though this device is reusable and designed to be used until blunted, it is for single-patient use to reduce the risk of cross-infection. Some types can be purposely broken into smaller segments to be used like a scalpel to cut tissue, e.g., during certain ophthalmologic surgical procedures. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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