FDA.report

8.6MHZ PENCIL PROBE 7'

Primary DI
00816787021172
Brand
8.6MHZ PENCIL PROBE 7'
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
832-1860-31
Published
2016-09-24
Public version status
Update
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

Contact Domains

Product Codes

CodeName
JOPTRANSDUCER, ULTRASONIC

Product Code Classifications

CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816787021172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787021172008167870211728167870211720816787021172

GMDN Terms

TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)547-6427twelker@parksmed.com

Regulatory Flags

DUNS number
009041773
Device count
1
DM exempt
true
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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008167870243268.1MHz Pencil Probe 7 Foot ODU connector832-1811-012022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connector832-1831-012022-05-15
008167870243408.7MHz Pencil Probe 7 Foot ODU connector832-1871-012022-05-15
008167870243579.1MHz Pencil Probe 7 Foot ODU connector832-1911-012022-05-15
008167870243649.4MHz Pencil Probe 7 Foot ODU connector832-1941-012022-05-15
008167870243719.7MHz Pencil Probe 7 Foot ODU connector832-1971-012022-05-15
008167870243028.1 MHz Pencil Probe 7FT Contoured832-0810-332021-05-15
0081678702427219-B IR REMOTE RECEIVER300-0376-002018-10-08
00816787024289REFURBISHED 19-B IR REMOTE RECEIVER301-0376-002018-10-08
0081678702010618-B IR REMOTE RECEIVER300-0277-012016-09-24
0081678702011318-B REFURB. IR REMOTE REC.300-0277-252016-09-24
00816787020120FINAL ASSY 2100-REMOTE 18-BR300-0302-012016-09-24
008167870201372100-SX & 3100-B REMOTE CHARG-300-0314-012016-09-24
00816787020144REFURBISHED 18-BR REMOTE301-0302-002016-09-24
00816787020151REFURBISHED 2100-SX/3100-B IR301-0314-002016-09-24
008167870241732100-SX2 FINAL FEATURE ITEM2100-SX2 FFI2016-09-24
008167870200078.2MHZ PENCIL PROBE 841-A832-1820-212016-09-24
00816787020014DOPPLER MODEL 1050-C W/PPG1050-C2016-09-24

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