FDA.report

NETWORK

Primary DI
05060165013951
Brand
NETWORK
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
10-151
Device description
10-151 NETWORK Epistaxis Slimpack 5.5cm
Published
2019-08-06
Public version status
Update
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
05060165013951PrimaryGS10
05056100706392Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060165013951050601650139515060165013951
05056100706392050561007063925056100706392

GMDN Terms

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

Regulatory Flags

DUNS number
458670304
Device count
20
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
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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05056100713055Lions World Vision InstituteLWVI-850-9.002025-03-11
05056100713062Lions World Vision InstituteLWVI-850-9.252025-03-11
05060165010349NETCELL30-3002019-08-06
05060165010363NETCELL30-305 2019-08-06
05060165010387NETCELL30-3102019-08-06
05060165013098NETCELL30-3152019-08-06

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