FDA.reportPublic FDA data

Industrial Finger Split

Primary DI
B54111067010
Brand
Industrial Finger Split
Company
FARETEC, INC.
Model
Industrial Finger Splint
Catalog number
1106701
Device description
Industrial Finger Splint Kit contains 27 assorted sizes and types of finger splints.
Published
2021-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
B54111067010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand/finger splint, single-useA 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 single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-440-350-9510colleen@faretec.com

Regulatory Flags#

DUNS number
626802540
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
B54133311420IFAKUNICEF IFAK KIT33311422026-05-12
B54133311410IFAKIFAK LOT 4 33311412026-01-12
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B54133311390IFAKIFAK 5033311392025-04-18
B54133311380IFAKIFAK 4933311382025-03-28
B54133311370IFAKIFAK 4833311372025-03-14
B54133310470IFAKCombat Casualty IFAK (DLIFAK)33310472025-02-26
B54133311360IFAKIFAK 4733311362025-01-31
B54170019070IFAKTactical Medical Kit, Backpack70019072025-01-31
B54170019080IFAKTactical Medical Bag-Component70019082025-01-31
B54133311350IFAKIFAK 4633311352024-12-11
B54133311340IFAKUN IFAK Advanced Lot 3 Plus33311342024-12-04
B54133311320IFAKIFAK Kit Advanced33311322024-06-14
B54133311310IFAKIFAK 4433311312024-06-10
B54133311300IFAKUN IFAK Advanced33311302024-05-09
B54180030080Pelvic BinderPelvic Binder, Coyote Brown80030082024-02-28
B54133311280IFAKIFAK 4333311282024-01-26
B54133311250IFAKIFAK 4033311252023-12-20
B54133311260IFAKIFAK 4133311262023-12-20
B54133311270IFAKIFAK 4233311272023-12-20

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