FDA.reportPublic FDA data

SHAW SCALPEL

Primary DI
00850007350260
Brand
SHAW SCALPEL
Company
C2DX, INC.
Model
7023-5712
Device description
MODEL 5712 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
Rx
false
OTC
false
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
K002021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002021000HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADEGyrus Ent LLC2000-08-24GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850007350267PrimaryGS10
00850007350260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000735026710850007350267
00850007350260008500073502608500073502600850007350260

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
116981210
Device count
10
DM exempt
false
Premarket exempt
false
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

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

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