Arjo Wiggins Medical, Inc.

Primary DI
00815588022005
Brand
Arjo Wiggins Medical, Inc.
Company
STERIMED INC.
Model
101088AJW1818
Catalog number
101088AJW1818
Device description
47_88 ARJOWRAP 18X18
Published
2016-09-21
Public version status
Update
Distribution status
Not 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
00815588022005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815588022005008155880220058155880220050815588022005

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
+1(843)388-8080michelle.pendergraph@sterimed.us

Regulatory Flags#

DUNS number
182052670
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013676PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013683PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014888PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014895PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014901PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015014PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015021PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015038PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015045PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015090PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015106PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013003PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013027PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013034PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013041PRIMEDpriMED Medical Products IncFRG2026-05-29