Invotec Quick Pack Nasal Balloon Packing

Primary DI
10818501020680
Brand
Invotec Quick Pack Nasal Balloon Packing
Company
INVOTEC INTERNATIONAL, INC.
Model
20-10715
Catalog number
20-10715
Device description
Invotec Quick Pack 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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EMXBalloon, Epistaxis

Product Code Classifications

CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818501020680PackageGS12In Commercial Distribution
00818501020683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102068010818501020680
00818501020683008185010206838185010206830818501020683

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
622812592
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10818501021182Invotec Silicone Sheeting20-2068520-206852022-12-07
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00818501021222Invotec Silicone Sheeting20-3000720-300072022-12-07
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00818501021246Invotec Silicone Sheeting20-3001520-300152022-12-07
00818501021253Invotec Silicone Sheeting20-3002020-300202022-12-07
00818501021260Invotec Silicone Sheeting20-3003020-300302022-12-07
00818501021277Invotec Silicone Sheeting20-3004020-300402022-12-07
00818501021284Invotec Silicone Sheeting20-3005020-300502022-12-07
00818501021291Invotec Silicone Sheeting20-3006020-300602022-12-07
00818501021307Invotec Silicone Sheeting20-30040R20-30040R2022-12-07
00818501021314Invotec Silicone Sheeting20-30030R20-30030R2022-12-07
00818501021321Invotec Silicone Sheeting20-30020R20-30020R2022-12-07
00818501021338Invotec Silicone Sheeting20-30015R20-30015R2022-12-07
00818501021345Invotec ENT BurBC-70050BC-705002022-12-07

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