FDA.report

BIOS Living

Primary DI
10057475210448
Brand
BIOS Living
Company
Thermor Ltd
Model
LK044
Device description
Adjustable Wrist Support Brace
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10057475210448PackageGS16In Commercial Distribution
00057475210441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521044810057475210448
00057475210441000574752104410574752104410057475210441

GMDN Terms

TermDefinition
Hand/finger splint, single-useA 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 single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
20057475260945BIOS LivingLF0942024-08-19
20057475260952BIOS LivingLF0952024-08-19
20057475260976BIOS LivingLF0972024-08-19
20057475260990BIOS LivingLF0992024-08-19
10057475267756BIOS LivingLF7752024-08-19
10057475267763BIOS LivingLF7762024-08-19
10057475281943BIOS LivingLH1942024-08-19
10057475283008BIOS LivingLH3002024-08-19
10057475960015BIOS LivingSP0012024-08-19
20057475611037BIOS LivingFA1032024-07-02
20057475611044BIOS LivingFA1042024-07-02
20057475611051BIOS LivingFA1052024-07-02
20057475611068BIOS LivingFA1062024-07-02
20057475611075BIOS LivingFA1072024-07-02
20057475611204BIOS LivingFA1202024-07-02
10057475160514BIOS DiagnosticsNS1602024-06-17

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