FDA.reportPublic FDA data

WOODCAST

Primary DI
06430053264359
Brand
WOODCAST
Company
Dassiet Oy
Model
C1434
Device description
Casting and splinting product
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430053264342PrimaryGS10
06430053264359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430053264342064300532643426430053264342
06430053264359064300532643596430053264359

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358504664642info@dassiet.com

Regulatory Flags#

DUNS number
651254398
Device count
20
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 DI, Brand, Model table
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
06450053264302UCASTU-TOE2022-09-30
06430053263123UCASTU-FINGER-SM2022-09-30
06430053263130UCASTU-FINGER-ML2022-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196284192MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
40080196832331MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
50192253045862WebrilCardinal Health 200, LLCITG2025-09-23
50192253045879WebrilCardinal Health 200, LLCITG2025-09-23
50192253045886WebrilCardinal Health 200, LLCITG2025-09-23
50192253045923WebrilCardinal Health 200, LLCITG2025-09-23
16975675788557RESCUE ESSENTIALSEMSRUN GROUPITG2025-07-18
07290100665619Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665626Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665633Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665640Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
00840117344389CurPro Undercast Padding, 100% Polyester, 2" x 4 yd Dynarex CorporationITG2025-06-05
00810180842099CurPro Undercast Padding , 100% Polyester, 3" x 4 yd Dynarex CorporationITG2025-06-05
00810180842105CurPro Undercast Padding, 100% Polyester, 4" x 4 yd Dynarex CorporationITG2025-06-05
00810180842112CurPro Undercast Padding, 100% Polyester, 6" x 4 yd Dynarex CorporationITG2025-06-05
00810180842129CurPro Undercast Padding, 100% Polyester, 8" x 4 ydDynarex CorporationITG2025-06-05
20192253045755CurityCardinal Health 200, LLCITG2025-03-19
50192253045763CurityCardinal Health 200, LLCITG2025-03-19
20192253045779CurityCardinal Health 200, LLCITG2025-03-19
20192253045793CurityCardinal Health 200, LLCITG2025-03-19
00840117342019CurPro Tubular Elastic Dressing Retention Net, 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342026CurPro Tubular Elastic Dressing Retention Net, 1 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342033CurPro Tubular Elastic Dressing Retention Net, 2.3" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342040CurPro Tubular Elastic Dressing Retention Net, 3.2" x 25 yd. Dynarex CorporationITG2025-02-17
50885632106512MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50885632106536MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50197106823017CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
06430053260238WOODCASTDassiet OyITG2024-08-11
06430053260252WOODCASTDassiet OyITG2024-08-11
06430053265837WOODCASTDassiet OyITG2024-08-11