FDA.reportPublic FDA data

Planatome®

Primary DI
00860003534663
Brand
Planatome®
Company
ENTREPIX MEDICAL, LLC
Model
PL-11
Device description
Planatome #11 Scalpel
Published
2020-10-01
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

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
00860003534663PackageGS110In Commercial Distribution
00860003534670PackageGS150In Commercial Distribution
00860003534618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003534663008600035346638600035346630860003534663
00860003534670008600035346708600035346700860003534670
00860003534618008600035346188600035346180860003534618

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
Weight0.459Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080998543
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003534687Planatome®PL-152020-10-01
00860003857809Planatome®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