FDA.reportPublic FDA data

Advanced Med-Surg Concepts

Primary DI
00841019110195
Brand
Advanced Med-Surg Concepts
Company
Advanced Med-Surg Concepts, Inc
Model
301-203
Device description
Monopolar Endoscopic Cord, 10ft. (3m)
Published
2016-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K913514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913514000ELECTROSURGICAL UNIT CABLEKirwan Surgical Products, Inc.1991-11-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019110192PackageGS110In Commercial Distribution
20841019110199PackageGS150In Commercial Distribution
00841019110195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911019210841019110192
2084101911019920841019110199
00841019110195008410191101958410191101950841019110195

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500kprario@ksp.com
781-834-9500mprario@ksp.com

Regulatory Flags#

DUNS number
177905486
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841019110102Advanced Med-Surg Concepts104-0002016-07-10
00841019110119Advanced Med-Surg Concepts104-0012016-07-10
00841019110126Advanced Med-Surg Concepts104-6022016-07-10
00841019110133Advanced Med-Surg Concepts191-0032016-07-10
00841019110140Advanced Med-Surg Concepts191-003C2016-07-10
00841019110157Advanced Med-Surg Concepts191-2302016-07-10
00841019110164Advamced Med-Surg Concepts191-2402016-07-10
00841019110171Advanced Med-Surg Concepts193-0022016-07-10
00841019110188Advanced Med-Surg Concepts193-010C2016-07-10
20841019110106Advanced Med-Surg Concepts104-0002016-07-10
30841019110110Advanced Med-Surg Concepts104-0012016-07-10
20841019110120Advanced Med-Surg Concepts104-6022016-07-10
20841019110137Advanced Med-Surg Concepts191-0032016-07-10
20841019110144Advanced Med-Surg Concepts191-003C2016-07-10
20841019110151Advanced Med-Surg Concepts191-2302016-07-10
20841019110168Advamced Med-Surg Concepts191-2402016-07-10
20841019110175Advanced Med-Surg Concepts193-0022016-07-10
20841019110182Advanced Med-Surg Concepts193-010C2016-07-10
20841019110199Advanced Med-Surg Concepts301-2032016-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
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