FDA.reportPublic FDA data

Silicone Flat Drain

Primary DI
14710961935183
Brand
Silicone Flat Drain
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2014-3102
Published
2022-01-31
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
GCDConnector, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14710961935183PrimaryGS10
04710961935186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471096193518314710961935183
04710961935186047109619351864710961935186

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Regulatory Flags#

DUNS number
656763489
Device count
10
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937223PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937377PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937384PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937391PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937407PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937339PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-07
14026704911858PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
10192253042900ArgyleCardinal Health 200, LLCGCD2025-03-07
10192253042832ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042856ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042863ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042870ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042887ArgyleCardinal Health 200, LLCGCD2025-02-27
14026704933126PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933133PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933140PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933157PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14710961934964Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961934971Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961934988Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961934995Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935008Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935015Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935022Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935039Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935046Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935053Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935060Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935077Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935084Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31