FDA.reportPublic FDA data

Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)

Primary DI
06938535543034
Brand
Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)
Company
Huaiyin Medical Instruments Co., Ltd.
Model
19#
Published
2025-09-05
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
06938535543034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938535543034069385355430346938535543034

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544611650
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938535542884Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)9#2025-09-05
06938535542891Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)10#2025-09-05
06938535542914Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)11#2025-09-05
06938535542945Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)12#2025-09-05
06938535542969Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)13#2025-09-05
06938535542976Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)14#2025-09-05
06938535542983Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)15#2025-09-05
06938535543003Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)16#2025-09-05
06938535543010Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)17#2025-09-05
06938535543027Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)18#2025-09-05
06938535543041Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)20#2025-09-05
06938535543058Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)21#2025-09-05
06938535543065Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)22#2025-09-05
06938535543072Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)23#2025-09-05
06938535543089Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)24#2025-09-05
06938535543096Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)25#2025-09-05
06938535543102Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)26#2025-09-05
06938535543119Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)27#2025-09-05
06938535543126Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)34#2025-09-05
06938535543133Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)36#2025-09-05

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Primary DI, Brand, Company table
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07613327651218VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651225VersiQuadSTRYKER CORPORATIONGES2026-07-16
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