FDA.reportPublic FDA data

BAHADIR USA

Primary DI
00858307007891
Brand
BAHADIR USA
Company
BAHADIR USA LLC
Model
Y808.00
Device description
M-Series Filter Retention Plate
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131407000BAHADIR STERILIZATION TRAYSBahadir USA Corp.2014-08-12KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858307007891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858307007891008583070078918583070078910858307007891

GMDN Terms#

Term, Definition table
TermDefinition
Device 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.

Contacts#

Phone, Email table
PhoneEmail
856-517-3080info@bahadirusa.com

Regulatory Flags#

DUNS number
794759212
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B060Y857470BAHADIR USAY857.472025-09-25
B060Y857750BAHADIR USAY857.752025-05-12
B060Y34010W17BAHADIR USAY 340.13W2024-09-10
00858307007730BAHADIR USAY801.012024-04-04
00858307007839BAHADIR USAY211.202024-02-20
00858307007846BAHADIR USAY311.102024-02-20
00858307007853BAHADIR USAY311.132024-02-20
00858307007860BAHADIR USAY311.152024-02-20
00858307007877BAHADIR USAY311.202024-02-20
00858307007884BAHADIR USAY311.262024-02-20
00858307007747BAHADIR USAY111.102023-09-05
B060Y54113A0BAHADIR USAY 541.13A2024-02-28
B060Y800003BAHADIR USA Y800.002020-02-26
B060Y800005BAHADIR USA Y800.002017-02-17
B060Y801001BAHADIR USA Y801.002017-02-17
B060Y802004BAHADIR USA Y802.002017-02-17
B060Y804004BAHADIR USA Y804.002017-02-17
B060Y807001BAHADIR USA Y807.002017-02-17
B060Y809001BAHADIR USA Y809.002017-02-17
00859982006254BAHADIR USAY800.009707012016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437695MilleniumAvalign Technologies, Inc.KCT2026-10-20
00385640095174INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095181INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095198INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095204INSTRUSAFESummit Medical, Inc.KCT2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
10886982312327NASynthes GmbHKCT2026-10-16
10886982346704VOLTSynthes GmbHKCT2026-10-16
10886982346735VOLTSynthes GmbHKCT2026-10-16
10886982363282NASynthes GmbHKCT2026-10-16
10886982363299NASynthes GmbHKCT2026-10-16
10886982363305NASynthes GmbHKCT2026-10-16
10886982363312NASynthes GmbHKCT2026-10-16
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15