FDA.reportPublic FDA data

Advamced Med-Surg Concepts

Primary DI
00841019110164
Brand
Advamced Med-Surg Concepts
Company
Advanced Med-Surg Concepts, Inc
Model
191-240
Device description
"Disposable Bipolar Forceps 5 1/2"" (14cm) Semkin, 0.7mm Tip and 12ft. (3.6m) Cable"
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
K900533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900533000DISPOSABLE BIPOLAR COAGULATING FORCEPSKirwan Surgical Products, Inc.1990-04-09GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019110161PackageGS110In Commercial Distribution
20841019110168PackageGS150In Commercial Distribution
00841019110164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911016110841019110161
2084101911016820841019110168
00841019110164008410191101648410191101640841019110164

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500mprario@ksp.com
781-834-9500kprario@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
00841019110171Advanced Med-Surg Concepts193-0022016-07-10
00841019110188Advanced Med-Surg Concepts193-010C2016-07-10
00841019110195Advanced Med-Surg Concepts301-2032016-07-10
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
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21