FDA.report

iCE boom and Pendant

Primary DI
00684706002140
Brand
iCE boom and Pendant
Company
Amico Clinical Solutions Corp
Model
iCE - Spectra LP
Catalog number
LP-L-18NN-R-E
Device description
Spectra LP Electric Series - Single Mount Dual Arm 1000-800 Reverse
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00684706002140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00684706002140006847060021406847060021400684706002140

GMDN Terms

TermDefinition
General utility supply system, ceiling-mountedAn assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
(905) 764-0800agarciadeparedes@amico.com

Regulatory Flags

DUNS number
243821688
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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