FDA.reportPublic FDA data

FIRST BLADES DISPOSABLE SURGICAL BLADES

Primary DI
16945630133463
Brand
FIRST BLADES DISPOSABLE SURGICAL BLADES
Company
Sterilance Medical (Suzhou) Inc.
Model
Standard CS 21#
Published
2024-12-16
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
36945630133467PackageGS150In Commercial Distribution
16945630133463PrimaryGS10
06945630133466Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3694563013346736945630133467
1694563013346316945630133463
06945630133466069456301334666945630133466

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
No natural rubber latex
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
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