FDA.reportPublic FDA data

Klein

Primary DI
20841019110021
Brand
Klein
Company
Klein Surgical Systems, Inc.
Model
3021-03
Device description
Disposable 10ft. (3m) Monopolar Endoscopic Cord
Published
2016-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913514000ELECTROSURGICAL UNIT CABLEKirwan Surgical Products, Inc.1991-11-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841019110024PackageGS110In Commercial Distribution
20841019110021PackageGS150In Commercial Distribution
00841019110027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084101911002410841019110024
2084101911002120841019110021
00841019110027008410191100278410191100270841019110027

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA 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. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-834-9500kprario@ksp.com

Regulatory Flags#

DUNS number
072364974
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850048763644Klein SurgicalGI3000GI30002024-01-11
10850048763804Klein Surgical3021-033021-032023-08-31
30850048763808Klein Surgical3021-033021-032023-08-31
10850048763194Klein Surgical300-100-771300-100-7712023-07-17
10850048763200Klein Surgical300-100-772300-100-7722023-07-17
10850048763217Klein Surgical300-100-773300-100-7732023-07-17
10850048763224Klein Surgical300-100-774300-100-7742023-07-17
10850048763231Klein Surgical300-100-775300-100-7752023-07-17
10850048763248Klein Surgical300-100-776300-100-7762023-07-17
10850048763255Klein Surgical300-100-777300-100-7772023-07-17
10850048763262Klein Surgical300-100-778300-100-7782023-07-17
10850048763279Klein Surgical300-100-779300-100-7792023-07-17
10850048763286Klein Surgical300-100-789300-100-7892023-07-17
10850048763309Klein Surgical300-400-775300-400-7752023-07-17
10850048763354Klein Surgical300-410-775300-410-7752023-07-17
10850048763613Klein SurgicalGI1075UGI1075U2023-07-17
10850048763620Klein SurgicalGI1085UGI1085U2023-07-17
10850048763637Klein SurgicalGI1095UGI1095U2023-07-17
10850048763651Klein SurgicalGI9000GI90002023-07-17
00841019110027Klein3021-032016-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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