FDA.report

UCAST

Primary DI
06450053264302
Brand
UCAST
Company
Dassiet Oy
Model
U-TOE
Device description
Toe splint
Published
2022-09-30
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

Contact Domains

Product Codes

CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications

CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06450053264302PackageGS110In Commercial Distribution
06430053264069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06450053264302064500532643026450053264302
06430053264069064300532640696430053264069

GMDN Terms

TermDefinition
Cast construction materialA plastic, fibreglass, or plaster-containing substance (or other material) that is applied in layers around an injured body appendage to construct a stiff dressing (cast) in order to immobilize fractured bones, diseased joints, or painful sprains. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+358504664642info@dassiet.com

Regulatory Flags

DUNS number
651254398
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06430053260238WOODCASTC1465 Black2024-08-11
06430053260252WOODCASTB1565 Black2024-08-11
06430053265837WOODCASTB1580 Black2024-08-11
06430053269842PROCASTX04152024-08-05
06430053261549WOODCASTC1441 Black2024-03-21
06430053260207WOODCASTC14652022-09-30
06430053260214WOODCASTB15652022-09-30
06430053261389WOODCASTC1434 black2022-09-30
06430053261419WOODCASTC1434S2022-09-30
06430053261488WOODCASTC1434S Black2022-09-30
06430053261525WOODCASTC14412022-09-30
06430053264007UCASTU-WRIST2022-09-30
06430053264274UCASTU-THUMB-SH2022-09-30
06430053264328UCASTU-THUMB2022-09-30
06430053264335UCASTU-MC2022-09-30
06450053264296UCASTU-HUM-L2022-09-30
06450053264289UCASTU-HUM-R2022-09-30
06430053263123UCASTU-FINGER-SM2022-09-30
06430053263130UCASTU-FINGER-ML2022-09-30
06430053264090UCASTU-PATELLA2022-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16974500613446Ankle SupportGCMEDICA ENTERPRISE LTD.(WUXI)ITW2025-12-08
00810113682891ManaEZ Ankle 06 Extra SmallManamed, Inc.ITW2025-09-26
00810113682907ManaEZ Ankle 06 SmallManamed, Inc.ITW2025-09-26
00810113682914ManaEZ Ankle 06 MediumManamed, Inc.ITW2025-09-26
00810113682921ManaEZ Ankle 06 LargeManamed, Inc.ITW2025-09-26
00810113682938ManaEZ Ankle 06 Extra LargeManamed, Inc.ITW2025-09-26
00810113682945ManaEZ Ankle 06 Extra Extra LargeManamed, Inc.ITW2025-09-26
00810113683126ManaEZ Night Splint, Plantar Fasciitis, SmallManamed, Inc.ITW2025-09-26
00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
00810113683324ManaGO71 Ankle Brace Extra LargeManamed, Inc.ITW2025-09-26
00810113683331ManaGO71 Ankle Brace LargeManamed, Inc.ITW2025-09-26
00810113683348ManaGO71 Ankle Brace MediumManamed, Inc.ITW2025-09-26
00810113683355ManaGO71 Ankle Brace SmallManamed, Inc.ITW2025-09-26
00749756399333DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399340DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399357DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399364DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00749756399371DeRoyalDEROYAL INDUSTRIES, INC.ITW2025-07-30
00190446662563PROCAREDJO, LLCITW2025-07-10
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00819567017853ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017860ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017877ComfytopiaComfytopia, Inc.ITW2025-07-09
00819567017884ComfytopiaComfytopia, Inc.ITW2025-07-09
00854194003121ComfytopiaComfytopia, Inc.ITW2025-07-09