FDA.report

STRADIS HEALTHCARE

Primary DI
M7526891530
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
689-153
Published
2022-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PXCPersonal Protection Kit

Product Code Classifications

CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M7526891530PrimaryHIBCC0

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
174262477
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M7529992814655Stradis Medical, LLC.9992814652018-12-13
M7529992814665Stradis Medical, LLC.9992814662018-10-02
M7529992814705Stradis Medical, LLC.9992814702018-12-13
M7529992814715Stradis Medical, LLC.9992814712018-12-13
M7529992814725Stradis Medical, LLC.9992814722018-11-21
M7529992814735Stradis Medical, LLC.9992814732018-11-21
M7529992814745Stradis Medical, LLC.9992814742018-11-16
M7529992814755Stradis Medical, LLC.9992814752018-12-17
M7529992814765Stradis Medical, LLC.9992814762018-09-27
M7529992815585Stradis Medical, LLC.9992815582018-12-13
M752682PREG1Stradis Medical, LLC682-PREG2017-08-08
M75257032000STRADIS HEALTHCARE570-32002022-12-19
M75257032180STRADIS HEALTHCARE570-32182022-12-19
M75257032310STRADIS HEALTHCARE570-32312022-12-19
M75257032380STRADIS HEALTHCARE570-32382022-12-20
M7521000125Stradis Medical, LLC.1000122018-10-08
M7521000161Stradis Medical, LLC.1000162018-10-08
M7521000175Stradis Medical, LLC1000172018-10-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842209136025NARNORTH AMERICAN RESCUE, LLCPXC2025-08-25
20194717120077Regard™ROI CPS, LLCPXC2024-10-02
20194717120138Regard™ROI CPS, LLCPXC2024-10-02
20194717119910Regard™ROI CPS, LLCPXC2024-08-14
20194717119743Regard™ROI CPS, LLCPXC2024-06-20
00842209130665NARNORTH AMERICAN RESCUE, LLCPXC2024-04-29
20194717116049Regard™ROI CPS, LLCPXC2022-07-11
M7526892650STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-21
M7526871050STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-17
M7526894290STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-14
00612479259119McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259133McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00816703025734MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
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00816703028551MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
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00816703028599MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028612MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
10818634024838Bosma EnterprisesBosma EnterprisesPXC2021-07-02
10818634024845Bosma EnterprisesBosma EnterprisesPXC2021-07-02
10818634024852Bosma EnterprisesBosma EnterprisesPXC2021-07-02
10818634024869Bosma EnterprisesBosma EnterprisesPXC2021-07-02
10818634024876AFFLINKBosma EnterprisesPXC2021-07-02
10818634024883AFFLINKBosma EnterprisesPXC2021-07-02
10818634024890AFFLINKBosma EnterprisesPXC2021-07-02
10818634024906AFFLINKBosma EnterprisesPXC2021-07-02
10818634025002Bosma EnterprisesBosma EnterprisesPXC2021-07-02
20194717108839RegardROI CPS, LLCPXC2020-12-08
20194717108600Regard™ROI CPS, LLCPXC2020-10-16