FDA.reportPublic FDA data

PREFERRED MEDICAL PRODUCTS LLC

Primary DI
00680211003139
Brand
PREFERRED MEDICAL PRODUCTS LLC
Company
PREFERRED MEDICAL PRODUCTS, LLC
Model
SC-7577-G
Catalog number
SC-7577-G
Device description
"STERILE DISPOSABLE EQUIPMENT COVER- CART COVER 44"" X 31"" X 77"""
Published
2024-08-07
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
40680211003137PackageGS130In Commercial Distribution
00680211003139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4068021100313740680211003137
00680211003139006802110031396802110031390680211003139

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). 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
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
00680211002231PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-3036QC-EZ-30362016-08-30

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