FDA.report

Symmetry Olsen

Primary DI
30841785102463
Brand
Symmetry Olsen
Company
OLSEN MEDICAL, LLC
Model
20-0471R
Catalog number
20-0471R
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30841785102463PackageGS15In Commercial Distribution
00841785102462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084178510246330841785102463
00841785102462008417851024628417851024620841785102462

GMDN Terms

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

Regulatory Flags

DUNS number
079344210
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08714729797609Boston ScientificM005614402016-09-23
08714729797616Boston ScientificM005614502016-09-23
08714729797623Boston ScientificM005614602016-09-23
08714729797630Boston ScientificM005614702016-09-23
08714729797647Boston ScientificM005614802016-09-23
08714729797654Boston ScientificM005614902016-09-23
08714729797661Boston ScientificM005615002016-09-23
00841785113390Symmetry Surgicale2400-50e2400-502019-09-25
00841785113406Symmetry Surgicale2400-51e2400-512019-09-25
00841785113413Symmetry Surgicale2400-52e2400-522019-09-25
00841785113420Symmetry Surgicale2400-53e2400-532019-09-25
00841785113437Symmetry Surgicale2401-502019-09-25
00841785113444Symmetry Surgicale2401-51e2401-512019-09-25
00841785113451Symmetry Surgicale2401-52e2401-522019-09-25
00841785113468Symmetry Surgicale2401-53e2401-532019-09-25
30841785113384Symmetry Surgicale2504-01e2504-012019-07-02
30841785105730Symmetry Olsen20-2650K20-2650K2016-09-06
30841785105747Symmetry Olsen20-2920HK20-2920HK2016-09-06
30841785105754Symmetry Olsen20-2920K20-2920K2016-09-06
30841785105761Symmetry Olsen20-2960HK20-2960HK2016-09-08

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00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
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00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
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08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
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08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
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08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09