FDA.reportPublic FDA data

STRADIS

Primary DI
M7526875500
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
687-550
Device description
CUSTOM SURGICAL KIT
Published
2022-03-16
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
PWLOral Surgery Tray
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWLOral Surgery TrayDental1
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526875500PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525250271STRADIS525-027525-0272016-05-04
M7525250291STRADIS525-029525-0292016-05-04
M752525021R11STRADIS525-0212016-09-10
M752525027R11STRADIS525-0272016-09-10
M752525028R11STRADIS525-0282016-09-17
M752525029R11STRADIS525-0292016-09-17
M752525037R11STRADIS525-0372016-09-17
M752525038R10Stradis Medical, LLC.525-038 R12017-04-12
M752525038R11STRADIS525-0382016-09-10
M752525038SAR11STRADIS525-038SA2016-09-10
M752525065R11STRADIS525-0652016-09-10
M752525072R11STRADIS525-0722016-09-10
M7525250791STRADIS525-079525-0792016-05-04
M752525079R11STRADIS525-0792016-09-10
M752525083R11STRADIS525-0832016-09-10
M7525251551STRADIS525-1552016-09-17
M752525202R11STRADIS525-2022016-09-10
M752525462R11STRADIS525-4622016-09-10
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956610774CARDINAL HEALTHCardinal Health 200, LLCPWL2026-11-05
16942748415375AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-11-03
16942748496336AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-10-28
10198956602472CARDINAL HEALTHCardinal Health 200, LLCPWL2026-10-23
16942748430514AllesetGRI Medical & Electronic Technology Co., Ltd.PZG2026-10-15
05056785304678Enucleation Kit - Vision GiftBLINK MEDICAL LIMITEDPZG2026-09-25
D95516CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
D9555CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
D9558CASS1Paul BandittTerlain Enterprises, Inc.PWL2026-09-25
05056785304555Cannula Kit 1 - San JoseBLINK MEDICAL LIMITEDPZG2026-07-31
16931918180090InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-07-28
05404027449708Accord SetHasa OptixPZG2026-07-16
05056785303657CANNULA KIT 1 - KAISER PERMANENTE MARTINEZBLINK MEDICAL LIMITEDPZG2026-05-12
05056785303633Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2026-05-06
16931918100166InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918103310InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918105574InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
00841668123331KATENAKATENA PRODUCTS, INC.PZG2026-03-02
05056785303251Cataract Instrument Pack - UCMBLINK MEDICAL LIMITEDPZG2025-12-11
05056785303015Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303039Cataract Inst Set - Spokane AdamsBLINK MEDICAL LIMITEDPZG2025-11-12
10198956208735CARDINAL HEALTHCardinal Health 200, LLCPWL2025-10-13
05056785302773Cataract Kit – Oklahoma VABLINK MEDICAL LIMITEDPZG2025-10-10
00845819003138Surgeon's Choice CardOASIS MEDICAL, INC.PZG2025-10-02
05056785302599RC Kit 1BLINK MEDICAL LIMITEDPZG2025-09-18
05056785302520RC Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302544Stockton Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302575Stockton Kit 1BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302469Kaiser AMD Instrument SetBLINK MEDICAL LIMITEDPZG2025-08-26
10198956170124CARDINAL HEALTHCardinal Health 200, LLCPWL2025-08-19