FDA.reportPublic FDA data

Penguin RFA

Primary DI
07350096320395
Brand
Penguin RFA
Company
Integration Diagnostics Sweden AB
Model
Penguin RFA Instrument Kit OsseoFuse
Catalog number
55002-O
Published
2022-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143445000Tellos ISQ BuddyTellos Medical AB2016-01-07EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350096320388Direct MarkingGS10
07350096320395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350096320388073500963203887350096320388
07350096320395073500963203957350096320395

GMDN Terms#

Term, Definition table
TermDefinition
MultimeterA battery-powered electronic instrument intended to be used to measure the amount or strength of values of an electric current, usually voltage and resistance. Sometimes, by means of additional probes, determinations such as sound level, or any form of energy that can be converted into an electrical signal, can be made.

Regulatory Flags#

DUNS number
352736781
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350096320272Osseo 100+Osseo 100+ InstrumentY10041762024-10-30
07350096320234Osseo 100Osseo 100 SetY10041752022-03-01
07350096322207MulTipeg™MulTipeg™ 100551342022-03-08
07350096321460MulTipeg™MulTipeg™ 38550462022-03-01
07350096320081Penguin RFAPenguin RFA Instrument Kit550022022-03-01
07350096320128Penguin RFAPenguin RFA Instrument Kit Implant Swiss55002-I2022-03-01
07350096320135Penguin RFAPenguin RFA Instrument Kit Klockner White55002-KW2022-03-08
07350096320142Penguin RFAPenguin RFA Instrument Kit Klockner Black55002-KB2022-03-08
07350096320159Penguin RFAPenguin RFA Instrument Kit Neoss55002-N2022-03-01
07350096320166Penguin RFAPenguin RFA Instrument Kit Citagenix55002-C2022-03-08
07350096320210Penguin RFAPenguin RFA Instrument Kit Bredent55002-B2022-03-08
07350096320241Penguin RFAIS3 Instrument Kit 55002-HM2022-03-08
07350096320319Penguin RFAPenguin RFA Instrument Kit SIC55002-S2022-03-08
07350096320333Penguin IIPenguin II Instrument552412023-12-20
07350096320418Penguin MDIPenguin MDI Instrument552802023-12-21
07350096320432MulTipeg™MDI MulTipeg™ 151552822023-12-21
07350096320449Penguin MDIPenguin MDI Locking Screwdriver552832023-12-21
07350096321606MulTipeg™MulTipeg™ 52550602022-03-08
07350096321613MulTipeg™MulTipeg™ 53550612022-03-08
07350096321620MulTipeg™MulTipeg™ 54550622022-03-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
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