FDA.reportPublic FDA data

Symmetry Olsen

Primary DI
00841785111433
Brand
Symmetry Olsen
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
97501
Catalog number
97501
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K862367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862367000PRO-CLEANDermacare Products, Inc.1986-07-08

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30841785111434PackageGS1144In Commercial Distribution
00841785111433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084178511143430841785111434
00841785111433008417851114338417851114330841785111433

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical tip cleaning padA wad designed to be used to periodically wipe clean (i.e., remove eschar build-up) a tip (e.g., an electrode or blade) used in an electrically-mediated surgical technique for cutting, coagulating, or cauterizing tissue. The device is typically abrasive on one side to facilitate cleaning, and adhesive on the other side so that it may be conveniently affixed to an easy access object in the operative arena (e.g., surgical drape, mayo stand). It may include a radiopaque thread making it visible on x-ray. This is a single-use device.

Regulatory Flags#

DUNS number
027680821
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09