FDA.reportPublic FDA data

nxt™ Bipolar Forceps

Primary DI
04251388943809
Brand
nxt™ Bipolar Forceps
Company
adeor Medical AG
Model
wide flat handle, bayonet, non-stick silver
Catalog number
BIP075EUSU
Published
2022-08-11
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

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
K191847000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191847000Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar ForcepsAdeor Medical AG2020-05-22GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251388943809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251388943809042513889438094251388943809

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341188943
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251388961278PMT Drill Cutter 2.2 x 20 mm2103-2542026-04-02
04251388960530VELOCITY ALPHA ™MR conditional Nitrogen DISS female hand tight x 1DA-15UN-M2-DH2026-03-31
04251388910801VELOCITY ALPHA ™Foot control, pneumatic (MR conditional)ZMF-1502026-03-30
04251388924105VELOCITY ALPHA ™Wall-Tubing, open-end, (MR conditional)ZMW-1212026-03-30
04251388959954VELOCITY ALPHA ™straight nosepiece short, MR conditionalVMN-S1-MR2026-03-30
04251388959961VELOCITY ALPHA ™angled nosepiece XXL, MR conditionalVMN-A5-MR2026-03-30
04251388959978VELOCITY ALPHA ™Highspeed motor pneumatic, MR conditional 80.000 rZMM-100-MR2026-03-30
04251388960080HiCUT Burs2.2 mm neuro Matchstick, MR conditionalN22MR2026-03-30
04251388960097HiCUT Burs4.8 mm balltip, MR conditionalB48MR2026-03-30
04251388960103HiCUT Burs3.4 mm drill, MR conditionalDR34MR2026-03-30
04251388960110HiCUT Burs4.5 mm drill, MR conditionalDR45MR2026-03-30
04251388960431VELOCITY ALPHA ™Steri-Tray made from plastic, custom made for MR cPST-MR2026-03-30
04251388960448VELOCITY ALPHA ™"Wall-Tubing, 1/8"" NPT connector, (MR conditionalZMW-1222026-03-30
04251388961001VELOCITY ALPHA ™Motor tube, straight, MR conditionalZMW-110-MR2026-03-30
04251388960387HiCUT Burs7.5 mm balltipB752025-04-30
04251388958315HiCUT Burs4.0 mm balltip, smooth cutB40S2025-04-29
04251388959855HiCUT Burs8.0 mm diamond ball standardDB802025-04-29
04251388959985HiCUT Burs3.2 mm balltip, smooth cutB32S2025-04-29
04251388959992HiCUT Burs5.0 mm balltip, smooth cutB50S2025-04-29
04251388960004HiCUT Burs6.0 mm balltip, smooth cutB60S2025-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693362MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10