FDA.reportPublic FDA data

Planatome®

Primary DI
00860003534601
Brand
Planatome®
Company
Planatome, LLC
Model
PL-10
Device description
Planatome #10 Scalpel
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00860003534649PackageGS110In Commercial Distribution
00860003534656PackageGS150In Commercial Distribution
00860003534601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003534649008600035346498600035346490860003534649
00860003534656008600035346568600035346560860003534656
00860003534601008600035346018600035346010860003534601

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useA sterile 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.636Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080998543
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
00860003534618Planatome®PL-112020-10-01
00860003857885Planatome®GY-102024-04-17
00860003857892Planatome®GY-152024-04-17
00860011334705Planatome®GY-102024-04-17
00860011334712Planatome®GY-152024-04-17
00860003857823Planatome®UF-102023-10-04
00860003857847Planatome®UF-152023-10-04
00860003857830Planatome®UF-102023-10-04
00860003857854Planatome®UF-152023-10-04
00860003534625Planatome®PL-152020-10-01
00860003534632Planatome®PL-15C2020-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327651119VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651126VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651140VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651157VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651171VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651195VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651201VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651218VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651225VersiQuadSTRYKER CORPORATIONGES2026-07-16
00840456201701JMUJMU DENTAL, INCGES2026-06-22
00840456201718JMUJMU DENTAL, INCGES2026-06-22
00840456201725JMUJMU DENTAL, INCGES2026-06-22
00840456201732JMUJMU DENTAL, INCGES2026-06-22
00840456201749JMUJMU DENTAL, INCGES2026-06-22
00840456203170JMUJMU DENTAL, INCGES2026-06-22
00840456203187JMUJMU DENTAL, INCGES2026-06-22
00840456203194JMUJMU DENTAL, INCGES2026-06-22
00840456203200JMUJMU DENTAL, INCGES2026-06-22
00840456203217JMUJMU DENTAL, INCGES2026-06-22
00840456215692JMUJMU DENTAL, INCGES2026-06-22
00840456215708JMUJMU DENTAL, INCGES2026-06-22
00840456215715JMUJMU DENTAL, INCGES2026-06-22
00840456215722JMUJMU DENTAL, INCGES2026-06-22
00840456215920JMUJMU DENTAL, INCGES2026-06-22
00840456215937JMUJMU DENTAL, INCGES2026-06-22
00840456215944JMUJMU DENTAL, INCGES2026-06-22
00840456215951JMUJMU DENTAL, INCGES2026-06-22
00840456215968JMUJMU DENTAL, INCGES2026-06-22
00840456215982JMUJMU DENTAL, INCGES2026-06-22
00840456215999JMUJMU DENTAL, INCGES2026-06-22