FDA.reportPublic FDA data

Kronner Low Profile Scope Holder Gas Line Set

Primary DI
00856589007011
Brand
Kronner Low Profile Scope Holder Gas Line Set
Company
KRONNER PROTOTYPES, INCORPORATED
Model
1
Device description
Two flexible gas lines, that are able to withstand up to 150 PSI. Used for the Kronner Low Profile Scope Holder. Sterilized for single-use.
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000663000KRONNER LOW PROFILE SCOPE HOLDERKronner Prototypes, Inc.2000-05-02GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856589007066PackageGS125In Commercial Distribution
00856589007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856589007066008565890070668565890070660856589007066
00856589007011008565890070118565890070110856589007011

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
091301184
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856589007073Kronner Side-Kick High Pressure Gas Line SetHPL1-BL1-V22017-05-26
00856589007080Kronner Side-Kick High Pressure Gas Line SetHPL1-BL1-V22017-05-26
00856589007035VCM 40VCM-402017-05-26
00856589007042VCM 45VCM-452017-05-26
00856589007059VCM 50VCM-502017-05-26

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Primary DI, Brand, Company table
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