FDA.reportPublic FDA data

Arjo Wiggins Medical, Inc.

Primary DI
00815588020094
Brand
Arjo Wiggins Medical, Inc.
Company
STERIMED INC.
Model
1011001515
Catalog number
1011001515
Device description
100 15X15,1000_CASE TB
Published
2016-09-21
Public version status
Update
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
00815588020094PrimaryGS10
00815588020087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815588020094008155880200948155880200940815588020094
00815588020087008155880200878155880200870815588020087

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(843)388-8080mpendergraph@arjomedical.com

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
00815588025655STERIMED, INC.1010260I5472VA1010260I5472VA2021-03-24
00815588025679STERIMED, INC.1010378B4848VA1010378B4848VA2021-03-24
00815588025693STERIMED, INC.1010378B3636VA1010378B3636VA2021-03-24

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