FDA.report

Soft-Form™ Thermo Plastic External Nasal Splint

Primary DI
10818501022622
Brand
Soft-Form™ Thermo Plastic External Nasal Splint
Company
INVOTEC INTERNATIONAL, INC.
Model
20-10121
Catalog number
20-10121
Device description
Soft-Form™ Thermo Plastic External Nasal Splint, Custom Cut
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
false
Single use
true

Related Records

Product Codes

CodeName
EPPSplint, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
EPPSplint, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10818501022622PackageGS15In Commercial Distribution
00818501022625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081850102262210818501022622
00818501022625008185010226258185010226250818501022625

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
622812592
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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