FDA.report

NETCELL

Primary DI
05060165010400
Brand
NETCELL
Company
NETWORK MEDICAL PRODUCTS LIMITED
Model
30-320
Device description
NETCELL 9mm Ear Pack
Published
2019-08-06
Public version status
Update
Distribution status
Not 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
KCNEar Wick

Product Code Classifications

CodeDeviceSpecialtyClass
KCNEar WickEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060165010400PrimaryGS10
05056100703407Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060165010400050601650104005060165010400
05056100703407050561007034075056100703407

GMDN Terms

TermDefinition
Ear wick, non-biodegradableA non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
458670304
Device count
10
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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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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