FDA.reportPublic FDA data

NA

Primary DI
10886704075684
Brand
NA
Company
Medos International Sàrl
Model
82-6882
Catalog number
826882
Device description
Patient Monitor Interface Cable - GE (11 pin)
Published
2016-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704075684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670407568410886704075684

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Waste Electrical and Electronic Equipment
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10886705032501GRYPHON Flex2089582089582024-05-17
10705034165448COUGAR1891555141891555142015-09-24
10886705022649RIGIDLOOP2320092320092015-09-01
10886705022656RIGIDLOOP2320112320112015-09-01
10886705022663RIGIDLOOP2320142320142015-09-01
10886705022670RIGIDLOOP2320162320162015-09-01
10886705022687RIGIDLOOP2320172320172015-09-01
10886705022694RIGIDLOOP2320182320182015-09-01
10886705022700RIGIDLOOP2320192320192015-09-01
10886705022717RIGIDLOOP2320212320212015-09-01
10886705022724RIGIDLOOP2320222320222015-09-01
10886705022731RIGIDLOOP2320232320232015-09-01
10886705022755RIGIDLOOP2320282320282015-09-01
10886705022830RIGIDLOOP2320372320372015-09-01
10886705024070RIGIDLOOP2180342180342015-09-01
10886705024094RIGIDLOOP2324472324472015-09-01
10886705024100RIGIDLOOP2324482324482015-09-01
10886705024117RIGIDLOOP2324492324492015-09-01
10886705026012TRUESPAN ORTHOCORD2281512281512016-07-07
10886705026029TRUESPAN ORTHOCORD2281522281522016-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04057834023541Tunneling KIT CH8RAUMEDIC AGGWM2025-12-08
04057834090468Tunneling KIT CH12RAUMEDIC AGGWM2025-12-08
04057834026115NEUROVENT-PRAUMEDIC AGGWM2025-12-05
04057834082845NEUROVENTRAUMEDIC AGGWM2025-12-05
04057834082876NEUROVENT-IFD-SRAUMEDIC AGGWM2025-12-05
04057834082883NEUROVENT-IFD-RRAUMEDIC AGGWM2025-12-05
04057834082906NEUROVENT-TEMP-IFD-SRAUMEDIC AGGWM2025-12-05
04057834082913NEUROVENT-TEMP-IFD-RRAUMEDIC AGGWM2025-12-05
04057834082920NEUROVENT-P-TEMPRAUMEDIC AGGWM2025-12-05
04057834082937NEUROVENT-TEMPRAUMEDIC AGGWM2025-12-05
04057834082968NEUROVENT-PTORAUMEDIC AGGWM2025-12-05
04057834083026NEUROVENT-PTO 2LRAUMEDIC AGGWM2025-12-05
04057834088410NEUROVENT-PXRAUMEDIC AGGWM2025-12-05
04057834097559BOLT-DRILL KIT CH5RAUMEDIC AGGWM2025-12-05
04057834097566BOLT-DRILL KIT CH9RAUMEDIC AGGWM2025-12-05
04057834097610BOLT-DRILL KIT PTORAUMEDIC AGGWM2025-12-05
10850013266279IRRAflow Cranial Access BoltIrras USA, Inc.GWM2025-07-24
00763000950941Duet EDMSMEDTRONIC PS MEDICAL, INC.GWM2025-03-23
00763000950972Duet EDMSMEDTRONIC PS MEDICAL, INC.GWM2025-03-23
10381780544319Codman® CereLink®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGWM2025-03-12
07908398200268BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200275BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200282BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
07908398200299BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2024-08-28
00382830048835NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830048842NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059701NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059718NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059725NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10
00382830059732NatusNATUS MEDICAL INCORPORATEDGWM2024-07-10