FDA.reportPublic FDA data

BAHADIR USA

Primary DI
B060Y11170W05
Brand
BAHADIR USA
Company
BAHADIR USA LLC
Model
Y111.70W
Device description
Long Body Container with Perforated Bottom710x280x205MM
Published
2021-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B060Y11170W05PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
794759212
Device count
1
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

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