FDA.reportPublic FDA data

Chalgren

Primary DI
10816020021188
Brand
Chalgren
Company
CHALGREN ENTERPRISES
Model
261-1-72BTP
Device description
Micrograbber Clip Adapter, 78" black leadwire
Published
2021-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYATester, Electrode/Lead, Electroencephalograph
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYATester, Electrode/Lead, ElectroencephalographNeurology1
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816020021188PackageGS12In Commercial Distribution
00816020021181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081602002118810816020021188
00816020021181008160200211818160200211810816020021181

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-847-3994sales@jarisupply.com

Regulatory Flags#

DUNS number
085932630
Device count
1
DM exempt
false
Premarket exempt
true
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
00816020020450Chalgren263-9P-24BTP263-9P-24BTP2016-09-09
00816020020467Chalgren263-9P-24RTP263-9P-24RTP2016-09-09
00816020020474Chalgren264-9P-24TP264-9P-24TP2016-09-09
00816020020481Chalgren264-9P-36STP264-9P-36STP2016-09-09
00816020020498Chalgren265-9G-24BTP265-9G-24BTP2016-09-09
00816020020504Chalgren265-9G-24RTP265-9G-24RTP2016-09-09
00816020020511Chalgren265-9S-24BTP265-9S-24BTP2016-09-09
00816020020528Chalgren265-9S-24RTP265-9S-24RTP2016-09-09
00816020020535Chalgren265-9T-24BTP265-9T-24BTP2016-09-09
00816020020542Chalgren265-9T-24RTP265-9T-24RTP2016-09-09
00816020020559Chalgren266-9G-24TP266-9G-24TP2016-09-09
00816020020566Chalgren266-9S-24TP266-9S-24TP2016-09-09
00816020020573Chalgren266-9T-24TP266-9T-24TP2016-09-09
00816020020580Chalgren266-9G-36STP266-9G-36STP2016-09-09
00816020020597Chalgren266-9S-36STP266-9S-36STP2016-09-09
00816020020603Chalgren266-9T-36STP266-9T-36STP2016-09-09
00816020020610Chalgren277-930-24TP277-930-24TP2016-09-09
00816020020627Chalgren277-930-48TP277-930-48TP2016-09-09
00816020020634Chalgren277-930-36STP277-930-36STP2016-09-09
00816020020641Chalgren279-930-24TP279-930-24TP2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13