FDA.reportPublic FDA data

NETCELL

Primary DI
05060165010219
Brand
NETCELL
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
10-145
Device description
10-145 NETCELL 8.0 Epistaxis
Published
2019-08-06
Public version status
Update
Distribution status
Not 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
05060165010219PrimaryGS10
05056100703254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060165010219050601650102195060165010219
05056100703254050561007032545056100703254

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458670304
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060165012305Eyetec40-4162019-08-06
05056100707177Eyetec1-4162020-02-25
05060165013166NETCELL37-4162019-08-28
05056100712775Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712782Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712805Lions World Vision InstituteLWVI-850-9.502025-03-11
05056100712812Lions World Vision InstituteLWVI-850-6.502025-03-11
05056100712829Lions World Vision InstituteLWVI-850-6.752025-03-11
05056100712836Lions World Vision InstituteLWVI-850-7.002025-03-11
05056100712843Lions World Vision InstituteLWVI-850-7.252025-03-11
05056100712850Lions World Vision InstituteLWVI-850-7.502025-03-11
05056100712867Lions World Vision InstituteLWVI-850-7.752025-03-11
05056100712874Lions World Vision InstituteLWVI-850-8.002025-03-11
05056100712881Lions World Vision InstituteLWVI-850-8.252025-03-11
05056100712904Lions World Vision InstituteLWVI-850-8.752025-03-11
05056100712911Lions World Vision InstituteLWVI-850-9.002025-03-11
05056100712928Lions World Vision InstituteLWVI-850-9.252025-03-11
05056100712935Lions World Vision InstituteLWVI-850-6.002025-03-11
05056100712942Lions World Vision InstituteLWVI-850-6.252025-03-11
05056100712799Lions World Vision InstituteLWVI-850-9.752025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925034662Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925042391Gyrus ACMIGyrus ACMI, LLCEMX2024-07-25
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08904428722310OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722327OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722334OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722341OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11