FDA.reportPublic FDA data

N/A

Primary DI
00885825015602
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
225370
Device description
Soft Tissue Ablator 90 Electrode w/Integrated Handpiece
Published
2016-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012695000VANGUARD REPROCESSED ARTHROSCOPIC WANDSVanguard Medical Concepts, Inc.2001-10-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885825015603PackageGS14In Commercial Distribution
00885825015602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088582501560330885825015603
00885825015602008858250156028858250156020885825015602

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688771N/AD-ENS-AVHDX-CBLD-ENS-AVHDX-CBL2026-10-08
07613327666878N/ALXMJ23LLXMJ23L2026-06-25
07613327666885N/ALXMJ23SLXMJ23S2026-06-25
07613327666892N/ALXMJ44SLXMJ44S2026-06-25
07613327666908N/ALXMJ37SLXMJ37S2026-06-25
07613327666915N/ALXMJ44LLXMJ44L2026-06-25
07613327666922N/ALXMJ37LLXMJ37L2026-06-25
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015986504Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
00860015986511Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
00190776437602MillenniumAvalign Technologies, Inc.GEI2026-11-04
B382SD89259100Surgical DirectSurgical Direct, Inc.GEI2026-11-03
B382SD89519020Surgical DirectSurgical Direct, Inc.GEI2026-11-03
SD89839030Surgical DirectSurgical Direct, Inc.GEI2026-11-03
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
04048551432822ENDOMAT SELECTKarl Storz GmbH & Co. KGHRX2026-11-02
042503371190364K UHD Laminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371190434K UHD Laminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
042503371191354K UHD Laminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
042503371191424K UHD Laminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371191594K UHD Foraminoscope (4.7 WCh), comboJoimax GmbHHRX2026-11-02
042503371191664K UHD Foraminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
04250337120308Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120605Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
04250337120643Biportal Laminoscope, okularJoimax GmbHHRX2026-10-29
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