FDA.reportPublic FDA data

SMR MAXI CABINET, STAINLESS STEEL, DELUXE, STORAGE-NO ELECTRICAL

Primary DI
00810040252471
Brand
SMR MAXI CABINET, STAINLESS STEEL, DELUXE, STORAGE-NO ELECTRICAL
Company
GLOBAL SURGICAL CORPORATION
Model
S 168040
Published
2021-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ETFUnit, Examining/Treatment, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040252471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040252471008100402524718100402524710810040252471

GMDN Terms#

Term, Definition table
TermDefinition
ENT cabinetA stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824793335
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040253836REP KIT FOR A-SERIES SCOPEM A730RK2024-09-26
00810040254581LASER FILTER MODULEM 1047LFM2024-09-26
00810040255113HD CAMERA, 1080P V2, A-SERIESM A517HD1080V22024-09-26
00810040255342CAMERA, 4K, USB POWERM 517-4K2024-09-26
00810040255397HD CAMERA, 1080P V2, FOR M725 SYS, INT'LM 517HD1080V2-725I2024-09-26
00810040255403LED LIGHT SOURCE, A-SERIES, V2M A801-LEDV22024-09-26
00810040255434A-SERIES SUPPORT ARM, HORIZONTAL, V2M A730-HAV22024-09-26
00810040255441A-SERIES SUPPORT ARM, 45 DEGREE, V2M A730-45AV22024-09-26
00810040250989CAMERA COUPLER, T-MOUNT TO CANON "EF" MOUNTM 528XSLR-EOS2022-09-20
00810040250996CAMERA COUPLER, T-MOUNT TO NIKON "F" MOUNTM 528XSLR-F2022-09-20
00810040251009CAMERA COUPLER, T-MOUNT TO SONY "E" MOUNTM 528XSLR-NEX2022-09-20
00810040251016FLAT PANEL MONITOR, SELECT SIZE: 22"-31", SELECT COLOR: BLACK OR WHITEM 547FS222022-09-20
00810040251023WALLMOUNT FOR FLAT PANEL MONITOR, </= 45 poundsM 547FSWMB2022-09-20
00810040253706WALL MOUNT BOARD FOR 32" METAL STUDS, WHITEM W557-322021-09-21
00810040253713WALL MOUNT BOARD FOR 24" STUDS, WHITEM W5572021-09-21
00810040253720LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSIONS 740200LEDTT2021-09-21
00810040253737LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSIONS 740200LEDTT-2302021-09-21
00810040253744LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, 230VS 740200LED2302021-09-21
00810040253751OBJECTIVE LENS, F=250MM, FIXEDM 10302021-09-21
00810040253768OBJECTIVE LENS, F=200MM, FIXEDM 10312021-09-21

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00840183528447BR Surgical, LLCBR Surgical, LLCETF2024-11-07
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00840183528508BR Surgical, LLCBR Surgical, LLCETF2024-10-28
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00840183502997BR Surgical, LLCBR Surgical, LLCETF2024-07-23