FDA.reportPublic FDA data

Case Medical, Inc

Primary DI
00653159004315
Brand
Case Medical, Inc
Company
Case Medical Inc.
Model
BES00310
Catalog number
BES00310
Device description
BRACKET 28MM DIA. 2.2x1.6 in., (10/PK)
Published
2022-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HBRRack, Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBRRack, ClipNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653159004315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653159004315006531590043156531590043150653159004315

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rack instrument-holding insert, reusableA device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a plug-like cone with a hollow centre for instrument placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053057972
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653159014208CASE MEDICAL185008018500802026-06-08
00653159014215CASE MEDICAL185008118500812026-06-08
00653159014222CASE MEDICAL185008218500822026-06-08
00653159014239CASE MEDICAL185008318500832026-06-08
00653159014246CASE MEDICAL185008418500842026-06-08
00653159014253CASE MEDICAL185008518500852026-06-08
00653159014260CASE MEDICAL185009018500902026-06-08
00653159014277CASE MEDICAL185009118500912026-06-08
00653159014284CASE MEDICAL185009218500922026-06-08
00653159013232CASE MEDICAL973653197365312026-03-20
00653159013256CASE MEDICAL973653097365302026-03-20
00653159014062CASE MEDICAL973652997365292026-03-20
00653159014086CASE MEDICAL973652497365242026-03-20
00653159014123CASE MEDICAL973652397365232026-03-20
00653159014727CASE MEDICAL973652697365262026-03-20
00653159014734CASE MEDICAL973652797365272026-03-20
00653159014741CASE MEDICAL973652597365252026-03-20
00653159014987CASE MEDICAL973653497365342026-03-20
00653159015007CASE MEDICAL973652897365282026-03-20
00653159015182CASE MEDICAL973663297366322026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04946329206548Sugita Titanium Clip CaseMIZUHO CORPORATIONHBR2024-08-16
04946329206555Sugita Titanium Clip CaseMIZUHO CORPORATIONHBR2024-08-16
04946329389388SUGITA AVM Microclip II CASEMIZUHO CORPORATIONHBR2023-12-18
04946329389395SUGITA AVM Microclip II CASEMIZUHO CORPORATIONHBR2023-12-18
04946329389739SUGITA AVM Microclip II CASEMIZUHO CORPORATIONHBR2023-12-18
00653159004292Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004308Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004322Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004346Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004421Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004438Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004483Case Medical, IncCase Medical Inc.HBR2022-06-30
00653159004513Case Medical, IncCase Medical Inc.HBR2022-06-30
04946329189582Sugita Titanium Clip II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329189599Sugita Titanium Clip II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329189605Sugita Titanium Clip II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329189612Sugita Titanium Clip II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329189629Sugita Titanium Clip II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329194074Sugita Titanium Clips II Half CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206470Sugita Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206487Sugita Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206494Sugita Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206500Sugita Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206517Sugita Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206562Sugita Titanium Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329206579Sugita Titanium Clip CaseMIZUHO CORPORATIONHBR2022-04-05
04946329214598Sugita Titanium Clips II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329214604Sugita Titanium Clips II CaseMIZUHO CORPORATIONHBR2022-04-05
04946329221039Sugita Aneurysm Clip Organizational TrayMIZUHO CORPORATIONHBR2022-04-05
04946329221046Sugita T2 Clip TrayMIZUHO CORPORATIONHBR2022-04-05