FDA.reportPublic FDA data

FIRST BLADES DISPOSABLE SURGICAL BLADES

Primary DI
16945630133425
Brand
FIRST BLADES DISPOSABLE SURGICAL BLADES
Company
Sterilance Medical (Suzhou) Inc.
Model
Standard CS 11#
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
36945630133429PackageGS150In Commercial Distribution
16945630133425PrimaryGS10
06945630133428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3694563013342936945630133429
1694563013342516945630133425
06945630133428069456301334286945630133428

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
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
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