FDA.report

Sterile Stainless Blades

Primary DI
00620974002437
Brand
Sterile Stainless Blades
Company
Southmedic Incorporated
Model
73-0022
Catalog number
73-0022
Device description
#22 Sterile Stainless Blade
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GESBLADE, SCALPEL

Product Code Classifications

CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10620974002434PrimaryGS10
00620974002437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400243410620974002434
00620974002437006209740024376209740024370620974002437

GMDN Terms

TermDefinition
Scalpel blade, single-useA sterile 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

Contacts

PhoneEmail
+1(705)726-9383custserv@southmedic.com

Regulatory Flags

DUNS number
246848147
Device count
150
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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06938535542914Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
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