FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
10630094180301
Brand
Bioseal Inc.
Company
BIOSEAL
Model
18030/50
Device description
Jolly Tube
Published
2023-10-05
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

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094180301PackageGS150In Commercial Distribution
00630094180304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009418030110630094180301
00630094180304006300941803046300941803040630094180304

GMDN Terms#

Term, Definition table
TermDefinition
Laryngectomy tubeA hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160500040Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2025-10-28
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160382119MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-04
10653160381501MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-18
10653160381228MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160381334MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-10-11
10653160379874CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-09-11
10653160379232MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-08-28
10653160375128MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160375340MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-05-28
10653160374183CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-05-02
10653160369592CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-18
10653160369462CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-11
10653160369431CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160369448CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-12-08
10653160365815CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-09-05
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10705031470507MERSILENEETHICON, LLCKDC2023-05-30
10653160360766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-05-29
10653160359197CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2023-03-17
10810102270921Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270938Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270945Dermapac, Inc.Dermapac Inc.KDC2022-09-12
10810102270952Dermapac, Inc.Dermapac Inc.KDC2022-09-12