FDA.report

Medi-Cut Scalpel

Primary DI
00616784412016
Brand
Medi-Cut Scalpel
Company
DYNAREX CORPORATION
Model
4120
Device description
Medi-Cut Scalpel, Disposable, Sterile, #20
Published
2022-04-18
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

Related Records

Product Codes

CodeName
GDXScalpel, One-Piece

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784412030PackageGS110In Commercial Distribution
00616784412023PrimaryGS10
00616784412016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784412030006167844120306167844120300616784412030
00616784412023006167844120236167844120230616784412023
00616784412016006167844120166167844120160616784412016

GMDN Terms

TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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
false
No natural rubber latex
false
Sterilization required before use
false

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