FDA.reportPublic FDA data

Precision IE 4K

Primary DI
07613327416367
Brand
Precision IE 4K
Company
STRYKER CORPORATION
Model
0502-234-130
Catalog number
0502-234-130
Published
2019-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327416367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327416367076133274163677613327416367

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle30degree
Device Size Text, specify0
Length72Millimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854041116POWERPROConmed CorporationHRX2026-03-24
04056702011970PUREVUE™ FMSW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012137Tube set inflow 4-Spike adaptorW.O.M. World of Medicine GmbHHRX2026-03-10
00763000956028Tubing SetMEDTRONIC XOMED, INC.HRX2026-02-14
B382SD401290Surgical DirectSurgical Direct, Inc.HRX2026-02-09
B382SD401490Surgical DirectSurgical Direct, Inc.HRX2026-02-09
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHRX2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHRX2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHRX2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHRX2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHRX2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHRX2025-12-17
06938695521026DrillShanghai Kinetic Medical Co., Ltd.HRX2025-12-09
08800038029323SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24