FDA.report

UCAST

Primary DI
06450053264289
Brand
UCAST
Company
Dassiet Oy
Model
U-HUM-R
Device description
Humerus brace
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
IOYSupport, Arm

Product Code Classifications

CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06450053264289PackageGS110In Commercial Distribution
06430053264052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06450053264289064500532642896450053264289
06430053264052064300532640526430053264052

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
06450053264302UCASTU-TOE2022-09-30
06430053263123UCASTU-FINGER-SM2022-09-30
06430053263130UCASTU-FINGER-ML2022-09-30
06430053264090UCASTU-PATELLA2022-09-30

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