FDA.reportPublic FDA data

ROSPITAL PRODUCTOS MEDICOS

Primary DI
00812460024799
Brand
ROSPITAL PRODUCTOS MEDICOS
Company
ATLAS MEDICAL PRODUCTS LLC
Model
ESPWH
Catalog number
ESPWH
Device description
ELECTROSURGICAL PENCIL, STERILE, WHITE, W/HOLDER EA 50 PCS/BOX. 100PCS/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
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
10812460024796PackageGS150In Commercial Distribution
20812460024793PackageGS12In Commercial Distribution
00812460024799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081246002479610812460024796
2081246002479320812460024793
00812460024799008124600247998124600247990812460024799

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10812460020392ROSPITAL PRODUCTOS MEDICOSELSELS2024-08-23
00812460021484ROSPITAL PRODUCTOS MEDICOSELSPELSP2024-08-23
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
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
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