FDA.report

OSSEOUS External Aluminium Splints

Primary DI
08906039310498
Brand
OSSEOUS External Aluminium Splints
Company
EON MEDITECH PRIVATE LIMITED
Model
E6149S
Device description
External Aluminium Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal septal structure.
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EPPSplint, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
EPPSplint, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039310443PackageGS125In Commercial Distribution
08906039312515PackageGS110In Commercial Distribution
08906039310498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906039310443089060393104438906039310443
08906039312515089060393125158906039312515
08906039310498089060393104988906039310498

GMDN Terms

TermDefinition
External nasal splintA rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.

Device Sizes

TypeValueUnit
Height0.6Millimeter
Length33Millimeter
Width37.73Millimeter
Width56.91Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
930270428
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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08904428798377OSSEOUS-CapsuleEA9100182026-03-13
08904428747672OSSEOUS Blade - Inferior turbinate - N TypeEI22222024-07-10
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08904428747658OSSEOUS Blade-Straight Sinus Blades - N TypeEI22202024-07-10
08904428747641OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22192024-07-10
08904428747634OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22182024-07-10
08904428747627OSSEOUS Blade-Curved Sinus Blades - TypeEI22172024-07-10

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