FDA.reportPublic FDA data

Silicone T Drainage Set With Eyes

Primary DI
04711182608309
Brand
Silicone T Drainage Set With Eyes
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
1910-8220
Published
2023-10-24
Public version status
New
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
GCACatheter, Biliary, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980917000ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIRFortune Medical Instrument Corp.1998-05-27GCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711182608309PrimaryGS10
14711182608306Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711182608309047111826083094711182608309
1471118260830614711182608306

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainA flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.

Regulatory Flags#

DUNS number
656763489
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14711182607989FixPad Anchoring Device1800-00052021-11-15
04710961933472Silicone Supra-Pubic Catheter (Ordinary Balloon)1857-02122016-03-15
04710961934127Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02122016-03-11
04710961934134Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02142016-03-11
04710961934141Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02162016-03-11
04710961934158Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02182016-03-11
04710961934165Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02202016-03-11
04710961934172Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02222016-03-11
04710961934189Silicone Supra-Pubic Catheter (Ordinary Balloon)1890-02242016-03-11
04710961934196Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82122016-03-15
04710961934202Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82142016-03-15
04710961934219Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82162016-03-15
04710961934226Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82182016-03-15
04710961934233Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-8220 2016-03-15
04710961934240Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82222016-03-15
04710961934257Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon)1890-82242016-03-15
04710961937531Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02102016-03-15
04710961937548Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02122016-03-15
04710961937555Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02142016-03-15
04710961937562Silicone Supra-Pubic Catheter (Integrated Balloon)4890-02162016-03-15

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