FDA.report

Silicone Penrose Drain Tube

Primary DI
04710961934660
Brand
Silicone Penrose Drain Tube
Company
FORTUNE MEDICAL INSTRUMENT CORP.
Model
2010-0706
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCDConnector, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14710961934667PrimaryGS10
04710961934660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1471096193466714710961934667
04710961934660047109619346604710961934660

GMDN Terms

TermDefinition
Surgical capillary wound drain, luminal, synthetic polymerA sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
656763489
Device count
25
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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14711182608306Silicone T Drainage Set With Eyes1910-82202023-10-24
14711182608313Silicone T Drainage Set With Eyes1910-82242023-10-24
04711182608163Rystora Skin Protector-SpraySY010302022-01-31
04710961934844Silicone C.W.V. Reservoir2013-06152022-01-31
04710961934851Silicone C.W.V. Reservoir2013-06202022-01-31
04710961934868Silicone C.W.V. Reservoir2013-06402022-01-31
04710961934875Silicone C.W.V. Reservoir (Top Outlet)2013-16402022-01-31
04710961934882Silicone C.W.V. Reservoir2013-09102022-01-31
04710961934899Silicone C.W.V. Reservoir2013-09152022-01-31
04710961934905Silicone C.W.V. Reservoir2013-09202022-01-31
04710961934912Silicone C.W.V. Reservoir2013-09402022-01-31
04710961934967Silicone Flat Drain2014-00522022-01-31
04710961934974Silicone Flat Drain2014-00712022-01-31
04710961934981Silicone Flat Drain2014-00722022-01-31
04710961934998Silicone Flat Drain2014-01012022-01-31
04710961935001Silicone Flat Drain2014-01022022-01-31
04710961935018Silicone Flat Drain2014-01312022-01-31
04710961935025Silicone Flat Drain2014-01322022-01-31
04710961935032Silicone Flat Drain Kit2014-90512022-01-31
04710961935049Silicone Flat Drain Kit2014-90522022-01-31

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24026704933123PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933130PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933147PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933154PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
07540198003016FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
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04710961934974Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934981Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934998Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935001Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935018Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935025Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935032Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935049Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935056Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935063Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935070Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935087Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935094Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935100Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
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