FDA.reportPublic FDA data

90000 Safety Scalpel #3 Handle Stainless Steel

Primary DI
00787551012057
Brand
90000 Safety Scalpel #3 Handle Stainless Steel
Company
XODUS MEDICAL, INC.
Model
90000
Catalog number
90000
Device description
90000 Safety Scalpel #3 Handle Stainless Steel
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551012051PackageGS11In Commercial Distribution
00787551012057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101205120787551012051
00787551012057007875510120577875510120570787551012057

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

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