FDA.reportPublic FDA data

PREFERRED MEDICAL PRODUCTS, LLC

Primary DI
00680211002057
Brand
PREFERRED MEDICAL PRODUCTS, LLC
Company
PREFERRED MEDICAL PRODUCTS, LLC
Model
PC-0896-TF
Catalog number
PC-0896-TF
Device description
"STERILE DISPOSABLE EQUIPMENT COVER - PROBE COVER 8"" X 96"" - TAPE, TELESCOPIC FOLD"
Published
2016-08-30
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
10680211002054PackageGS120In Commercial Distribution
30680211002058PackageGS1100In Commercial Distribution
00680211002057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068021100205410680211002054
3068021100205830680211002058
00680211002057006802110020576802110020570680211002057

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
00680211003313PREFERRED MEDICAL PRODUCTS LLCEZ-1280-DDSEZ-1280-DDS2026-10-12
00680211003306PREFERRED MEDICAL PRODUCTS LLCMC-3018-DMC-3018-D2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPC-0824 W/BPC-0824 W/B2026-09-21
00680211003276PREFERRED MEDICAL PRODUCTS LLCC-ARM 2454C-ARM 24542026-07-06
00680211002040PREFERRED MEDICAL PRODUCTS, LLCPC-0896 W/BPC-0896 W/B2016-08-30
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

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