Easy Cut Splint

Primary DI
00198715553499
Brand
Easy Cut Splint
Company
Tacklebox Medical, LLC
Model
2513155
Device description
The Easy Cut Intranasal Splint is designed to maintain a nasal airway and provide septal support post-operatively after septal and/or cosmetic nasal surgery. As an added feature, the anterior tip of each splint has an elevated suture channel for suture placement through the splint and septum to prevent posterior dislodgement. The elevated suture channel provides easy access to the suture and aids in suture removal. Each splint has an elevated suture channel on each end so that a splint can be used on the right or left side. The splints are supplied sterile in packages containing two (2) splints. There are five (5) packages in a box.
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYASplint, Intranasal Septal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYASplint, Intranasal SeptalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198715553499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715553499001987155534991987155534990198715553499

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

Contacts#

Phone, Email table
PhoneEmail
210.201.5478support@easycutsplint.com

Regulatory Flags#

DUNS number
091289530
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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