FDA.report

Marina Medical

Primary DI
00840306830709
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
040-070L-LC
Catalog number
040-070L-LC
Device description
Scalpel Handle #3 Long - for Blade sizes #10-18: 20cm/8in LASER COATED
Published
2024-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GESBLADE, SCALPEL

Product Code Classifications

CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306830709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306830709008403068307098403068307090840306830709

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length20Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00840306837227Marina Medical1570-BR21570-BR22025-08-08
00840306837234Marina Medical1570-BR31570-BR32025-08-08
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00840306837265Marina Medical1570-BR101570-BR102025-08-08
00840306837180Marina Medical110-346110-3472025-07-02
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00840306837173Marina Medical050-964050-9642025-06-04
00840306805882Marina MedicalR642.07R642.072025-04-04
00840306812026Marina Medical180-140180-1402025-03-12
00840306830938Marina Medical20-017020-01702025-03-12
00840306830945Marina Medical20-017420-01742025-03-12
00840306836466Marina Medical200-262200-2622025-03-07

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