FDA.reportPublic FDA data

ROSPITAL PRODUCTOS MEDICOS

Primary DI
10812460020392
Brand
ROSPITAL PRODUCTOS MEDICOS
Company
ATLAS MEDICAL PRODUCTS LLC
Model
ELS
Catalog number
ELS
Device description
ELECTROSURGICAL PENCIL EA. 50PCS/BOX. 4BOXES/CASE
Published
2024-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K170369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170369000Disposable Electrosurgical PencilsCathay Manfacturing Corp.2018-07-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812460020392PackageGS150In Commercial Distribution
20812460020399PackageGS14In Commercial Distribution
00812460020395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002039210812460020392
2081246002039920812460020399
00812460020395008124600203958124600203950812460020395

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar 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 intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-4739436INFO@VIONOVA.COM

Regulatory Flags#

DUNS number
013112308
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812460027035Rospital Productos MedicosSY10WNSY10WN2020-06-13
00812460027059Rospital Productos MedicosSY10215SY102152020-06-13
00812460020777Rospital Productos MedicosGS4021262022-10-21
00812460020821Rospital Productos MedicosCW500101CW5001012022-10-21
00812460021965Rospital Productos MedicosGS4021284021282022-10-21
00812460025086Rospital Productos MedicosGS402122GS4021222022-10-21
00812460028131Rospital Productos MedicosFM3501FM35012020-09-29
00812460020395ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
00812460024799ROSPITAL PRODUCTOS MEDICOSESPWHESPWH2024-08-23
00812460024768Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
00812460024775Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
00812460024782Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
00812460026243Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16
00812460026274Rospital Productos MedicosSY1WN3012SY1WN30122024-04-16
00812460026298Rospital Productos MedicosSY1WN31516SY1WN315162024-04-16
10812460024765Rospital Producos MedicosSY05WN31516SY05WN315162024-04-16
10812460024772Rospital Productos MedicosSY05WN32516SY05WN325162024-04-16
10812460024789Rospital Productos MedicosSY05WN3012SY05WN30122024-04-16
10812460026240Rospital Productos MedicosSY1WN32516SY1WN325162024-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16