FDA.reportPublic FDA data

PREFERRED MEDICAL PRODUCTS, LLC

Primary DI
00680211002828
Brand
PREFERRED MEDICAL PRODUCTS, LLC
Company
PREFERRED MEDICAL PRODUCTS, LLC
Model
PD-2424
Catalog number
PD-2424
Device description
"STERILE DISPOSABLE EQUIPMENT COVERS - TABLE COVER 24"" X 24"""
Published
2019-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863853000EAZY COVERSSuperior Medical Products1987-03-06JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10680211002825PackageGS120In Commercial Distribution
30680211002829PackageGS1100In Commercial Distribution
00680211002828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068021100282510680211002825
3068021100282930680211002829
00680211002828006802110028286802110028280680211002828

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
161770292
Device count
1
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
00680211003276PREFERRED MEDICAL PRODUCTS LLCC-ARM 2454C-ARM 24542026-07-06
00680211002040PREFERRED MEDICAL PRODUCTS, LLCPC-0896 W/BPC-0896 W/B2016-08-30
00680211002057PREFERRED MEDICAL PRODUCTS, LLCPC-0896-TFPC-0896-TF2016-08-30
00680211002064PREFERRED MEDICAL PRODUCTS, LLCPC-1.3836 W/SPC-1.3836 W/S2016-08-30
00680211002071PREFERRED MEDICAL PRODUCTS, LLCPC-1000PC-10002016-08-30
00680211002088PREFERRED MEDICAL PRODUCTS, LLCPC-1072-TFPC-1072-TF2016-08-30
00680211002095PREFERRED MEDICAL PRODUCTS, LLCPC-1480-TFPC-1480-TF2016-08-30
00680211002101PREFERRED MEDICAL PRODUCTS, LLCPD-2754PD-27542016-08-30
00680211002118PREFERRED MEDICAL PRODUCTS, LLCPD-3624PD-36242016-08-30
00680211002125PREFERRED MEDICAL PRODUCTS, LLCPD-4470PD-44702016-08-30
00680211002132PREFERRED MEDICAL PRODUCTS, LLCPD-4482PD-44822016-08-30
00680211002149PREFERRED MEDICAL PRODUCTS, LLCPD-4545PD-45452016-08-30
00680211002156PREFERRED MEDICAL PRODUCTS, LLCPD-5454PD-54542016-08-30
00680211002163PREFERRED MEDICAL PRODUCTS, LLCPD-5470PD-54702016-08-30
00680211002170PREFERRED MEDICAL PRODUCTS, LLCPD-5490PD-54902016-08-30
00680211002187PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-12QC-EZ-122016-08-30
00680211002194PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-20QC-EZ-202016-08-30
00680211002200PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-2015QC-EZ-20152016-08-30
00680211002217PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-28QC-EZ-282016-08-30
00680211002224PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-3014.5QC-EZ-3014.52016-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.JAA2026-07-08
00680211003276PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-07-06
00848340021879Mitaka DrapeADVANCE MEDICAL DESIGNS, INC.JAA2026-06-25
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.JAA2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.JAA2026-04-30
08809244060533GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060557GenorayGENORAY CO., LTD.JAA2026-04-10
08809244060632GenorayGENORAY CO., LTD.JAA2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSJAA2025-12-17
08809244060618GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060625GenorayGENORAY CO., LTD.JAA2025-12-01
08809244060700GenorayGENORAY CO., LTD.JAA2025-12-01
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHJAA2025-07-30
04056869993980LUMINOS Q.namix TSiemens Healthcare GmbHJAA2025-07-30
08800018422601EXTRON 3DRTECH CorporationJAA2025-06-17
08809244060090GenorayGENORAY CO., LTD.JAA2025-05-02
00643169618121O-armMEDTRONIC NAVIGATION, INC.JAA2024-10-10
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-10-09
00190376601182IntraOp Alignment SystemALPHATEC SPINE, INC.JAA2024-10-01
00193982184506EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00193982184537EXCELSIUS3DGLOBUS MEDICAL, INC.JAA2024-06-26
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195278719720AlliaGE MEDICAL SYSTEMSJAA2023-12-08
08800018420805EXTRON 5DRTECH CorporationJAA2023-08-24
08800018420904EXTRON 7DRTECH CorporationJAA2023-08-24