FDA.reportPublic FDA data

SHAW SCALPEL

Primary DI
20850007350301
Brand
SHAW SCALPEL
Company
C2DX, INC.
Model
7023-5815
Device description
MODEL 5815 BLADE - QTY 10
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183009000HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADESHemostatix Medical Technologies, LLC2018-11-26GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850007350301PrimaryGS10
00850007350307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000735030120850007350301
00850007350307008500073503078500073503070850007350307

GMDN Terms#

Term, Definition table
TermDefinition
Haemostatic knifeA hand-operated surgical instrument, similar in appearance to a surgical scalpel, designed for simultaneous cutting of tissues and cauterization (haemostasis) of blood vessels by applying an electrically-heated blade. It typically consists of a high-resistance, flat, sharp blade at the distal end and a handle at the proximal end with an electric cable; the blade is typically an integral part of the knife. Haemostasis is induced by direct transmission of thermal energy (heat) from the blade to the tissues; negating the use of grounding electrodes. It is used for a variety of procedures, including general and plastic surgery, gynaecology, and orthopaedics. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
888-902-2239SALES@C2DX.COM

Regulatory Flags#

DUNS number
116981210
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007350321Wire GuideC-SF-15-502026-02-10
00850007350338Salivary Access Dilator SetSDDS-18-20-HC2026-02-10
00850007350345Kolenda Salivary Introducer Set - 5.0SDAS-5.0-182026-02-10
00850007350352Kolenda Salivary Introducer Set - 6.0SDAS-6.0-182026-02-10
00850007350369NGage Salivary Stone ExtractorSSEB-1.7-115-82026-02-10
00850007350376NCircle Tipless Salivary Stone ExtractorSSEB-1.5-115-102026-02-10
00850007350383Sialocath Salivary Duct CatheterSDC-2.2-202026-02-10
00850007350390Advance Salivary Duct Balloon Catheter Set - 1.5SDBS-14-30-1.5-22026-02-10
00850007350406Advance Salivary Duct Balloon Catheter Set - 2.0SDBS-14-30-2.0-22026-02-10
00850007350413Advance Salivary Duct Balloon Catheter Set - 2.5SDBS-14-30-2.5-22026-02-10
00850007350420Advance Salivary Duct Balloon Catheter Set - 3.0SDBS-14-30-3.0-22026-02-10
10850007350090Mul-T-Pad8002-062-6122024-01-09
10850007350106Mul-T-Pad8002-062-6222024-01-09
10850007350120Mul-T-Pad8002-062-6262024-01-09
20850007350073Mul-T-Pad8002-062-0222024-01-09
20850007350110T/Pad8002-062-2222024-01-09
00850007350154TPS2TPS22024-01-09
00850007350161TPT9TPT92024-01-09
00850007350178TPIVTPIV2024-01-09
10850007350212SHAW SCALPEL7023-57102023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12