FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M7526821425R10
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
682-1425R1
Published
2022-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PYBMinor Surgical Procedures Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7526821425R10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

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
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
00844107000996Arbutus MedicalArbutus Medical IncPYB2026-09-24
00844107001009Arbutus MedicalArbutus Medical IncPYB2026-09-24
00844107000897Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000903Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000934Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000958Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000972Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000989Arbutus MedicalArbutus Medical IncPYB2026-06-22
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
10197106029916CARDINAL HEALTHCardinal Health 200, LLCPYB2022-11-18
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
H65857030875Henry ScheinHENRY SCHEIN, INC.PYB2022-05-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00844107000637Arbutus MedicalArbutus Medical IncPYB2021-10-19
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31
00884450055144PAL™Merit Medical Systems, Inc.PYB2018-09-17
00884450166062Merit Medical®Merit Medical Systems, Inc.PYB2018-09-17
00884450049556Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049570Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049587Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049594Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14