FDA.reportPublic FDA data

Invotec Post Stat

Primary DI
00818501020676
Brand
Invotec Post Stat
Company
INVOTEC INTERNATIONAL, INC.
Model
20-10710
Catalog number
20-10710
Device description
Posterior Nasal Balloon Packing, Silicone
Published
2022-12-06
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
EMXBalloon, Epistaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818501020673PackageGS11In Commercial Distribution
00818501020676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102067310818501020673
00818501020676008185010206768185010206760818501020676

GMDN Terms#

Term, Definition table
TermDefinition
Nasal haemostatic balloonA device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.

Regulatory Flags#

DUNS number
622812592
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818501023158Invotec Forceps 129-808002023-07-18
00818501021161Invotec Silicone Sheeting20-2068020-206802022-12-07
00818501021178Invotec Silicone Sheeting20-2068220-206822022-12-07
00818501021185Invotec Silicone Sheeting20-2068520-206852022-12-07
00818501021956Invotec PVA Nasal Dressing22-6040022-604002022-12-07
00818501021963Invotec PVA Nasal Dressing22-60400P22-60400P2022-12-07
00818501021970Invotec PVA Nasal Dressing22-6040222-604022022-12-07
00818501021987Invotec PVA Nasal Dressing22-60402P22-60402P2022-12-07
00818501021994Invotec PVA Nasal Dressing22-6040622-604062022-12-07
00818501022007Invotec PVA Nasal Dressing22-60406P22-60406P2022-12-07
00818501022014Invotec PVA Nasal Dressing22-6040922-604092022-12-07
00818501022021Invotec PVA Nasal Dressing22-60409P22-60409P2022-12-07
00818501022038Invotec PVA Nasal Dressing22-6041022-604102022-12-07
00818501022045Invotec PVA Nasal Dressing22-60410P22-60410P2022-12-07
00818501022052Invotec PVA Nasal Dressing22-6041122-604112022-12-07
00818501022069Invotec PVA Nasal Dressing22-60411P22-60411P2022-12-07
00818501022076Invotec PVA Nasal Dressing22-6041322-604132022-12-07
00818501022083Invotec PVA Nasal Dressing22-60413P22-60413P2022-12-07
00818501022090Invotec PVA Nasal Dressing22-6041422-604142022-12-07
00818501022106Invotec PVA Nasal Dressing22-6042122-604212022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00821925042391Gyrus ACMIGyrus ACMI, LLCEMX2024-07-25
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