FDA.reportPublic FDA data

Front1 Health Partners

Primary DI
27290110066004
Brand
Front1 Health Partners
Company
DEGANIA SILICONE LTD
Model
11006802880F1
Device description
Straight silicone thoracic catheter 28Fr
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBSCatheter, Ventricular, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBSCatheter, Ventricular, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290110066004PackageGS110In Commercial Distribution
47290110066008PackageGS110In Commercial Distribution
07290110066000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729011006600427290110066004
4729011006600847290110066008
07290110066000072901100660007290110066000

GMDN Terms#

Term, Definition table
TermDefinition
Surgical capillary wound drain, non-luminalA sterile device, without a lumen, 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 available as a corrugated drainage sheet or ribbon made of non-latex materials [e.g., polyvinyl chloride (PVC), silicone], and may include radiopaque markers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600007082
Device count
1
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884522000017Covidien AG90051T2025-04-03
30884522000028Covidien AG90052T2025-04-03
30884522000035Covidien AG90053T2025-04-03
30884522000042Covidien AG90054T2025-04-03
30884522000059Covidien AG90055T2025-04-03
30884522000066Covidien AG90056T2025-04-03
20884522000014Covidien AG90051T2025-04-03
10884522000024Covidien AG90052T2025-04-03
10884522000031Covidien AG90053T2025-04-03
10884522000048Covidien AG90054T2025-04-03
10884522000055Covidien AG90055T2025-04-03
10884522000062Covidien AG90056T2025-04-03
07290110066512Covidien AG102201101680TY2025-03-04
27290110066516Covidien AG102201101680TY2025-03-04
07290110066475Covidien AG102201100880TY2025-02-20
07290110066482Covidien AG102201101080TY2025-02-20
07290110066499Covidien AG102201101280TY2025-02-20
07290110066505Covidien AG102201101480TY2025-02-20
07290110066529Covidien AG102201101880TY2025-02-20
27290110066479Covidien AG102201100880TY2025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00736239051000Novo VivoGenesis Industries, IncorporatedGBS2023-09-12
14710961935961Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935978Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935985Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935992Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936005Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936012Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936029Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936036Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936043Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936050Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936067Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936074Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936081Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936098Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936104Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936128Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936135Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936142Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936159Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936166Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936173Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936180Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936197Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936203Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936210Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936227Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936234Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936241Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14711182605572Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15