Rochester

Primary DI
10816843021303
Brand
Rochester
Company
ROCHESTER ELECTRO-MEDICAL, INC.
Model
S0152015
Device description
NASOPHARYNGEAL ELECTRODES: SILVER BALL ELECTRODE, 6 FT. (1.8 M), SINGLE, SILICONE WIRE
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZKElectrode, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZKElectrode, NasopharyngealNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816843021303PrimaryGS10
10816843021310Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081684302130310816843021303
1081684302131010816843021310

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal electrodeAn electrical conductor intended to be temporarily placed in the nasopharyngeal region to record electrical activity. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18003285544info@rochestermed.com

Regulatory Flags#

DUNS number
068156330
Device count
2
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816843021235Rochester2220002016-09-24
10816843021259Rochester2221112016-09-24
10816843021273Rochester2224662016-09-24
10816843020009Rochester0322382016-09-24
10816843020023Rochester0325432016-09-24
10816843020047Rochester0356872016-09-24
10816843020061Rochester0356892016-09-24
10816843020085Rochester0383752016-09-24
10816843023741Rochester2220002016-09-24
10816843023765Rochester2221112016-09-24
10816843021297Rochester2224662016-09-24
10816843020276EverLast™BMS017T15-42016-09-24
10816843020290EverLast™BMS037T15-102016-09-24
10816843020313EverLast™BMS037T15-42016-09-24
10816843020337EverLast™BMS037T15-52016-09-24
10816843020351EverLast™BMS037T15-62016-09-24
10816843020375EverLast™BMS037T15-82016-09-24
10816843020399UltraLast™BMS042T15-42016-09-24
10816843020412UltraLast™BMS042T15-52016-09-24
10816843020436UltraLast™BMS042T15-62016-09-24