FDA.report

SMR MAXI CABINET, ALUMINUM COMPOSITE, DELUXE, NO OTOSCOPES, CANADA

Primary DI
00810040253102
Brand
SMR MAXI CABINET, ALUMINUM COMPOSITE, DELUXE, NO OTOSCOPES, CANADA
Company
GLOBAL SURGICAL CORPORATION
Model
S 378070D
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

Related Records

Product Codes

CodeName
ETFUnit, Examining/Treatment, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810040253102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040253102008100402531028100402531020810040253102

GMDN Terms

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

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

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