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
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14