FDA.reportPublic FDA data

McKie Thumb Splint Neonatal

Primary DI
00810026960031
Brand
McKie Thumb Splint Neonatal
Company
McKie Splints, LLC
Model
N1-L Red
Device description
McKie Thumb Splint - Neonatal Size 1 - Left Hand - Red Color
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILHSplint, Hand, And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810026960031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810026960031008100269600318100269600310810026960031

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, reusableA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2187202844info@mckiesplints.com

Regulatory Flags#

DUNS number
028744055
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810026962165McKie Thumb Splint AdultA1-L Black2023-06-29
00810026962189McKie Thumb Splint AdultA1-L Pink2023-06-29
00810026962196McKie Thumb Splint AdultA1-L Red2023-06-29
00810026962202McKie Thumb Splint AdultA1-L Royal2023-06-29
00810026962219McKie Thumb Splint AdultA1-L Tan2023-06-29
00810026962226McKie Thumb Splint AdultA1-R Black2023-06-29
00810026962240McKie Thumb Splint AdultA1-R Pink2023-06-29
00810026962257McKie Thumb Splint AdultA1-R Red2023-06-29
00810026962264McKie Thumb Splint AdultA1-R Royal2023-06-29
00810026962271McKie Thumb Splint AdultA1-R Tan2023-06-29
00810026962288McKie Thumb Splint AdultA2-L Black2023-06-29
00810026962301McKie Thumb Splint AdultA2-L Pink2023-06-29
00810026962318McKie Thumb Splint AdultA2-L Red2023-06-29
00810026962325McKie Thumb Splint AdultA2-L Royal2023-06-29
00810026962332McKie Thumb Splint AdultA2-L Tan2023-06-29
00810026962349McKie Thumb Splint AdultA2-R Black2023-06-29
00810026962363McKie Thumb Splint AdultA2-R Pink2023-06-29
00810026962370McKie Thumb Splint AdultA2-R Red2023-06-29
00810026962387McKie Thumb Splint AdultA2-R Royal2023-06-29
00810026962394McKie Thumb Splint AdultA2-R Tan2023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101258DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101357DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101456DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427006BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427013BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427020BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427037BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427044BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427051BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427068BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427075BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427082BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271427099BLACK FOAM WRISTDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610484SPLINT, WRIST, LACE-UP, RIGHT, X-SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610491SPLINT, WRIST, LACE-UP, RIGHT, SMALLDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271610507SPLINT, WRIST, LACE-UP, RIGHT, MEDIUMDARCO INTERNATIONAL, INC.ILH2023-02-08