FDA.reportPublic FDA data

SURGICAL BLADE

Primary DI
16945630117432
Brand
SURGICAL BLADE
Company
Sterilance Medical (Suzhou) Inc.
Model
10-0115C
Published
2023-03-21
Public version status
New
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
36945630117436PackageGS150In Commercial Distribution
16945630117432PrimaryGS10
06945630117435Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3694563011743636945630117436
1694563011743216945630117432
06945630117435069456301174356945630117435

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
554434897
Device count
100
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
16945630137799STERiLANCE"""SteriHeel 2 0.65mm×1.4mm"""2026-04-19
16945630137805STERiLANCE"""SteriHeel 2 0.85mm×1.75mm"""2026-04-19
16945630137812STERiLANCE"""SteriHeel 2 1.0mm×2.5mm"""2026-04-19
16945630137829STERiLANCE"""SteriHeel 2 2.0mm×3.0mm"""2026-04-19
16945630142724STERiLANCESoft 32G2026-03-31
16945630141987STERiLANCEElite 30G 1.8mm2026-03-09
16945630141994STERiLANCE Press2 26G 1.8mm2026-03-09
16945630142007STERiLANCELDE42026-03-09
16945630142014STERiLANCESoft 28G2026-03-09
16945630142021STERiLANCESoft 30G2026-03-09
16945630142038STERiLANCESoft 32G2026-03-09
16945630142045STERiLANCESoft 33G2026-03-09
16945630142069STERiLANCELite3 30G 1.8mm2026-03-09
36945630141981STERiLANCEElite 30G 1.8mm2026-03-09
06945630141997STERiLANCE Press2 26G 1.8mm2026-03-09
36945630142001STERiLANCELDE42026-03-09
36945630142018STERiLANCESoft 28G2026-03-09
36945630142025STERiLANCESoft 30G2026-03-09
36945630142032STERiLANCESoft 32G2026-03-09
36945630142049STERiLANCESoft 33G2026-03-09

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