FDA.reportPublic FDA data

FOMED

Primary DI
06973685040378
Brand
FOMED
Company
Fomed Industries Inc
Model
90 X 230 mm
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K143637000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143637000U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd.2015-09-09FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973685040378PrimaryGS10
46973685040376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973685040378069736850403786973685040378
4697368504037646973685040376

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.

Regulatory Flags#

DUNS number
653922539
Device count
2000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842942013058PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013065PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013072PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013089PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013096PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013102PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013188PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013195PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013201PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013218PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013225PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013232PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013249PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013256PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013423PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013430PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013447PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013454PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013461PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013478PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013607PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013614PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013621PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013638PRIMEDpriMED Medical Products IncFRG2026-05-29