FDA.reportPublic FDA data

Medline

Primary DI
10080196462414
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
WAG3V13ABA
Catalog number
WAG3V13ABA
Device description
Three Quarter Size Steristet Sterilizati
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
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
K041096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041096000WAGNER STERISET STERILIZATION CONTAINERWagner GmbH2005-06-03FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080196462414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019646241410080196462414

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5499service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

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