Sterimed

Primary DI
20850341007053
Brand
Sterimed
Company
STERIMED LLC
Model
0184
Device description
Band Bag 36" X 25"
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10850341007056PackageGS125In Commercial Distribution
20850341007053PackageGS14In Commercial Distribution
00850341007059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085034100705610850341007056
2085034100705320850341007053
00850341007059008503410070598503410070590850341007059

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

Contacts#

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

Regulatory Flags#

DUNS number
080284658
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
false
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
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

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