FDA.reportPublic FDA data

NS90150 Safety Cartridge #15 Stainless Blade Yellow Cartridge

Primary DI
00787551012170
Brand
NS90150 Safety Cartridge #15 Stainless Blade Yellow Cartridge
Company
XODUS MEDICAL, INC.
Model
NS90150
Catalog number
NS90150
Device description
NS90150 Safety Cartridge #15 Stainless Blade Yellow Cartridge
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551012174PackageGS1100In Commercial Distribution
00787551012170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101217420787551012174
00787551012170007875510121707875510121700787551012170

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use 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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00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
0078755104159040673 Hot Pink Pad EXT - with Arm Protectors40673406732026-04-30
0078755104160640674 Hot Pink Pad EXT40674406742026-04-30
00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
00787551041385LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
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