FDA.reportPublic FDA data

Sterimed

Primary DI
00867878000477
Brand
Sterimed
Company
STERIMED LLC
Model
4065X
Device description
"Equipment Cover 40"" X 65"" W/Tape"
Published
2018-10-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853044000STERICOVERSterimed, Inc.1985-11-01IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867878000474PackageGS125In Commercial Distribution
20867878000471PackageGS14In Commercial Distribution
00867878000477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086787800047410867878000474
2086787800047120867878000471
00867878000477008678780004778678780004770867878000477

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system coverA sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray systems cannot be sterilized, this device is draped over/attached to the x-ray system allowing its use without compromising the sterile field. It will also protect the x-ray system from patient contaminants. It is available in a variety of shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Radiation Sterilization"", ""Ethylene Oxide""]"
Radiation Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
770-387-0771xx@xx.xx

Regulatory Flags#

DUNS number
080284658
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850341007349SterimedMB00622016-09-19
00850341007356SterimedMB00962016-09-19
00850341007363SterimedMG01052016-09-19
00850341007370SterimedMR00822016-09-19
00850341007387SterimedMR01202016-09-19
00850341007394SterimedPB10032016-09-19
00850341007479SterimedWG01052016-09-19
00850341007486SterimedWR01202016-09-19
00850341007493SterimedWR01502016-09-19
00850341007509SterimedWR10102016-09-19
00850341007516SterimedZB10052016-09-19
00850341007523SterimedZG00822016-09-19
00850341007752SterimedMR01502016-09-19
00850341007776SterimedTR0105B2016-09-19
00850341007790SterimedZB00962016-09-19
00850341007806SterimedZG10012016-09-19
00850341007813SterimedZG10062016-09-19
00850341007905SterimedZG10072016-09-19
00860001790207Sterimed0888NT0888NT2019-05-16
00860001790214Sterimed3520SB2020-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
00860001790290SterimedSTERIMED LLCIZI2021-09-29
00860007655609SterimedSTERIMED LLCIZI2021-09-29
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
20193489066927NAMICMEDLINE INDUSTRIES, INC.IZI2021-05-12
00195278215543AlliaGE MEDICAL SYSTEMSIZI2021-03-31
00195278215550AlliaGE MEDICAL SYSTEMSIZI2021-03-31
10858701006213SPYNovadaq Technologies IncIZI2020-09-21
00860001790214SterimedSTERIMED LLCIZI2020-04-27
00810116023011Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00810116023028Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00840682147378INNOVAGE MEDICAL SYSTEMSIZI2020-02-03