FDA.reportPublic FDA data

PREFERRED MEDICAL PRODUCTS LLC

Primary DI
40680211003175
Brand
PREFERRED MEDICAL PRODUCTS LLC
Company
PREFERRED MEDICAL PRODUCTS, LLC
Model
SC-36100
Catalog number
SC-36100
Device description
STERILE DISPOSABLE EQUIPMENT COVER- DOME COVER 36" X 100" - SEWN CLOSURE
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
40680211003175PackageGS130In Commercial Distribution
00680211003177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4068021100317540680211003175
00680211003177006802110031776802110031770680211003177

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
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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