STERIMED, INC.

Primary DI
00815588025655
Brand
STERIMED, INC.
Company
STERIMED INC.
Model
1010260I5472VA
Catalog number
1010260I5472VA
Device description
STERISHEET RF 60I 54 X 72
Published
2021-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931202000STERILIZATION WRAP-STERISHEETArjo Wiggins Medical, Inc.1993-12-16FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815588025655PrimaryGS10
00815588025662Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815588025655008155880256558155880256550815588025655
00815588025662008155880256628155880256620815588025662

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(843)388-8080michelle.pendergraph@sterimed.us

Regulatory Flags#

DUNS number
182052670
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815588025921STERIMED, Inc.1010260I1818VA1010260I1818VA2021-10-26
00815588025945STERIMED, Inc.1010260I3030VA1010260I3030VA2021-10-26
00815588025914STERIMED, Inc.1010260I1818VA1010260I1818VA2021-10-26
00815588025938STERIMED, Inc.1010260I3030VA1010260I3030VA2021-10-26
00815588025860STERIMED, Inc.1010260I2424VA1010260I2424VA2021-10-20
00815588025884STERIMED, Inc.1010260I3636VA1010260I3636VA2021-10-20
00815588025907STERIMED, Inc.1010260I4040VA1010260I4040VA2021-10-20
00815588025853STERIMED, Inc.1010260I2424VA1010260I2424VA2021-10-20
00815588025877STERIMED, Inc.1010260I3636VA1010260I3636VA2021-10-20
00815588025891STERIMED, Inc.1010260I4040VA1010260I4040VA2021-10-20
00815588025815STERIMED, INC.1010360B5454BA1010360B5454VA2021-03-25
00815588025839STERIMED, INC.1010360B3636VA1010360B3636VA2021-03-25
00815588025822STERIMED, INC.1010360B5454BA1010360B5454BA2021-03-25
00815588025846STERIMED, INC.1010360B3636VA1010360B3636VA2021-03-25
00815588025594STERIMED, INC.1010160B4040VA1010160B4040VA2021-03-24
00815588025617STERIMED, INC.1010260I4848VA1010260I4848VA2021-03-24
00815588025631STERIMED, INC.1010260I5454VA1010260I5454VA2021-03-24
00815588025679STERIMED, INC.1010378B4848VA1010378B4848VA2021-03-24
00815588025693STERIMED, INC.1010378B3636VA1010378B3636VA2021-03-24
00815588025716STERIMED, INC.1010360B4040VA1010360B4040VA2021-03-24

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