FDA.reportPublic FDA data

MediChoice

Primary DI
10885632133671
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
SCPL11
Device description
Scalpel Surgical Safety Retractable Blade Stainless Steel Size 11 Disposable Sterile Not Made With Natural Rubber Latex MediChoice
Published
2020-09-24
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
30885632133675PackageGS110In Commercial Distribution
50885632133679PackageGS150In Commercial Distribution
10885632133671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088563213367530885632133675
5088563213367950885632133679
1088563213367110885632133671

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.

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632524790SurgiTrackSM450087D8CD2026-06-25
10885632524721SurgiTrackSM450070DAF72026-06-24
10885632524738SurgiTrackSM450071932C2026-06-24
10885632523267SurgiTrackSM45008746332026-06-10
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840456216002JMUJMU DENTAL, INCGES2026-06-22
00840456220641JMUJMU DENTAL, INCGES2026-06-22
00840456220658JMUJMU DENTAL, INCGES2026-06-22
00840456220665JMUJMU DENTAL, INCGES2026-06-22
00840456220672JMUJMU DENTAL, INCGES2026-06-22
00840456220689JMUJMU DENTAL, INCGES2026-06-22
00840456220696JMUJMU DENTAL, INCGES2026-06-22
00840456220702JMUJMU DENTAL, INCGES2026-06-22
00840456220719JMUJMU DENTAL, INCGES2026-06-22