FDA.reportPublic FDA data

8.3MHZ SKNY PEN PROBE 841-A

Primary DI
00816787022056
Brand
8.3MHZ SKNY PEN PROBE 841-A
Company
PARKS MEDICAL ELECTRONICS, INC.
Model
832-2830-21
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOPTRANSDUCER, ULTRASONIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816787022056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816787022056008167870220568167870220560816787022056

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)547-6427twelker@parksmed.com

Regulatory Flags#

DUNS number
009041773
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816787024388Remote Control RF 2100 With Pads300-0378-012025-07-18
008167870243193.9MHz Pencil Probe 7 Foot ODU connector832-1391-012022-05-15
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
008167870200078.2MHZ PENCIL PROBE 841-A832-1820-212016-09-24
008167870204588.2MHZ AVIAN INFANT832-0820-112016-09-24
008167870204658.5MHZ AVIAN INFANT832-0850-112016-09-24
008167870204728.9MHZ AVIAN INFANT832-0890-112016-09-24
008167870204899.2MHZ AVIAN INFANT832-0920-112016-09-24
008167870204969.3MHZ AVIAN INFANT832-0930-112016-09-24
008167870205029.5MHZ AVIAN INFANT832-0950-112016-09-24
008167870205199.7MHZ AVIAN INFANT832-0970-112016-09-24
008167870205263.9MHZ PENCIL PROBE832-1390-112016-09-24
008167870205333.9MHZ PENCIL PROBE 7'832-1390-312016-09-24
008167870205403.9MHZ PENCIL PROBE 10'832-1390-412016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.JOP2026-04-10
G677H1V06VasoGuardCorVascularJOP2026-04-08
G677H1V08VasoGuardCorVascularJOP2026-04-08
G677H1V10VasoGuardCorVascularJOP2026-04-08
G677H2V02VasoGuardCorVascularJOP2026-04-08
G677H2V04VasoGuardCorVascularJOP2026-04-08
G677VG0201VasoGuardCorVascularJOP2026-04-08
G677VG0401VasoGuardCorVascularJOP2026-04-08
G677VG0601VasoGuardCorVascularJOP2026-04-08
G677VG0801VasoGuardCorVascularJOP2026-04-08
G677VG1001VasoGuardCorVascularJOP2026-04-08
00888937027815CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
00888937027822CooperSurgical® Coopersurgical, Inc.JOP2025-09-25
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880533Falcon/XpressVIASONIX LTDJOP2024-12-27
07290016880489Pressure Cuff Size 12LVIASONIX LTDJOP2023-06-29
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15