FDA.reportPublic FDA data

BAHADIR USA

Primary DI
00859982006193
Brand
BAHADIR USA
Company
BAHADIR USA LLC
Model
Y820.03
Catalog number
971002
Device description
METAL ID LABEL, CUSTOM ENGRAVE, RED
Published
2017-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

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
00859982006193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859982006193008599820061938599820061930859982006193

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical 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 for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

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
00858307007891BAHADIR USAY808.002025-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23
00190776422004MillenniumAvalign Technologies, Inc.FSM2026-07-23
18059015378368Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378375Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
18059015378382Flexible Reamers SystemORTHOFIX SRLFSM2026-07-23
00841731153258ARTEMIS FUZEVILEX LLCFSM2026-07-22
00841731153265ARTEMIS TAKEDOWNVILEX LLCFSM2026-07-22
B803PW12A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW14G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW18A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW20ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW22A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW26A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW30A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW32A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW40A0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
B803PW6G0ORTHOMEDORTHO-MED, INC.FSM2026-07-22
00840606195737ViaductSPINAL ELEMENTS, INC.FSM2026-07-20
00843059127478LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FSM2026-07-20
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17