FDA.reportPublic FDA data

RODIN RF MICROSURGERY SET

Primary DI
00841494106812
Brand
RODIN RF MICROSURGERY SET
Company
Cynosure, LLC
Model
RODIN1
Catalog number
RODIN1
Device description
RODIN RF SET WITH HP, CABLE & 7 ACETIPS
Published
2016-09-21
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071343000ELLMAN NOBLE ALLOY ELECTRODESEllman International, Inc.2008-02-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494106812PrimaryGS10
00841494104481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494106812008414941068128414941068120841494106812
00841494104481008414941044818414941044810841494104481

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during argon-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
8
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100032SculpSure laser assembly100-7026-0102017-07-26
00841494100049SculpSure Applicator100-7026-1002017-07-26
00841494106867SculpSure Applicator, RefurbishedR100-7026-1002017-07-24
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUB100-7026-8162017-09-26
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLY100-7026-9102017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL100-7026-9202017-11-29
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYR100-7026-9102018-01-18
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24

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Primary DI, Brand, Company table
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B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
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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
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00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
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