AccessGUDID - DEVICE: WOODCAST (06430053261396)

GUDID

Device Identifier (DI) Information

Brand Name: WOODCAST
Version or Model: C1434 black
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dassiet Oy

Primary DI Number: 06430053261396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 651254398 *Terms of Use

Device Description: Casting and splinting product

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33056	Cast construction material	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITG	Bandage, Cast

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 578793f0-78d4-4eab-88ae-9513357b3a8b
Public Version Date: October 10, 2022
Public Version Number: 1
DI Record Publish Date: September 30, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 06430053261389 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +358504664642
Email: info@dassiet.com

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