Stradis Medical, LLC.

Primary DI
M752UPC502L5
Brand
Stradis Medical, LLC.
Company
STRADIS MEDICAL LLC
Model
UPC-502L
Device description
PERSONAL PROTECTION EQUIPMENT PACK
Published
2020-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXDPrep Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXDPrep KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752UPC502L5PackageHIBCC25In Commercial Distribution
M752UPC502L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-424-8520CS@stradishealthcare.com

Regulatory Flags#

DUNS number
043537671
Device count
1
DM exempt
false
Premarket exempt
false
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M752CPD20000Stradis Medical, LLCCPD-20002020-04-14
M752ACC26001Stradis Medical, LLC.ACC-26002019-09-24
M752DC1790920Stradis Medical, LLC.DC-17909-22020-06-10
M752HCT200GD20Stradis Medical, LLC.HCT200GD-22020-07-16
M752HCT6186CP10Stradis Medical, LLCHCT6186CP-12020-07-02
M752HCT8874VA20Stradis Medical, LLC.HCT8874VA-22019-10-08
M752HCT900AGD10Stradis Medical, LLC.HCT900AGD-12020-07-23
M752TM85161Stradis Medical, LLC.TM85162019-09-06
M752TM85170Stradis Medical, LLC.TM.85172021-03-05
M752TM882310Stradis Medical, LLCTM8823-12019-06-21
M752TM882311Stradis Medical, LLCTM8823-12019-07-22
M752TMCLK10Stradis Medical, LLCTMCLK-12019-12-23
M752TMCLK20Stradis Medical, LLCTMCLK-22021-04-13
M752HCT900CHX0ARTERIAL LINE DRESSING CHANGE KITHCT900CHX2022-01-10
M752HCT6625CTA0Stradis Medical, LLC.HCT6625TC-A2020-07-13
M752HCT100GD20Stradis Medical, LLCHCT100GD-22020-07-16
M752TN170313069C0Stradis Medical, LLCTN1703-13069C2020-06-16
M752TSBRF6640Stradis Medical, LLCTSBRF-6642020-10-26
M752TSBRF6630Stradis Medical, LLCTSBRF-6632020-10-26
M752HCT8249CP3A0Stradis Medical, LLC.HCT8249CP-3A2020-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840365903055InvenioGri-Alleset, Inc.PXD2025-03-12
10840365903052InvenioGRI Medical & Electronic Technology Co., Ltd.PXD2025-03-12
10304040167721Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
10304040167943Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167724Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167946Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00883873772676Emergency Response KitPHYSIO-CONTROL, INC.PXD2023-03-12
M752UPC502L0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M5Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
H65857008711Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008721Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008731Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008741Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008751Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008761Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008715Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008725Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008735Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008745Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008755Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008765Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09