FDA.report

EXEL SCALPELS ,S-S, SIZE:10

Primary DI
10020221295501
Brand
EXEL SCALPELS ,S-S, SIZE:10
Company
Exel International
Model
29550
Catalog number
29550
Device description
EXEL SCALPELS ,S-S, SIZE:10; 10/BX, 100PCS/CS, 10CS/CRTN
Published
2023-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GESBlade, Scalpel

Product Code Classifications

CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10020221295501PackageGS110In Commercial Distribution
20020221295508PackageGS110In Commercial Distribution
30020221295505PackageGS110In Commercial Distribution
00020221295504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1002022129550110020221295501
2002022129550820020221295508
3002022129550530020221295505
00020221295504000202212955040202212955040020221295504

GMDN Terms

TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
180572216
Device count
1
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
04250381863572Scalpel handleSpiggle & Theis Medizintechnik GmbHGES2025-09-24
06938535542884Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542891Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542914Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542945Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542969Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542976Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535542983Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543003Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543010Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543027Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543034Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543041Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543058Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543065Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543072Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543089Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543096Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543102Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543119Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543126Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543133Sterile Disposable Surgical Blade without Plastic Handle (Stainless Steel)Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543232Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543249Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543263Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543294Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543317Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543324Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543331Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05
06938535543355Sterile Disposable Surgical Blade without Plastic Handle (Carbon Steel )Huaiyin Medical Instruments Co., Ltd.GES2025-09-05