AccessGUDID - DEVICE: Lyofoam® Max T (07332551999759)

GUDID

Device Identifier (DI) Information

Brand Name: Lyofoam® Max T
Version or Model: 603207
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mölnlycke Health Care AB

Primary DI Number: 07332551999759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631770658 *Terms of Use

Device Description: Lyofoam Max T 9cmx9cm x 10pcs

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?
15624	Tracheostomy tube dressing	A pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, wound, hydrophilic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9cm x 9cm

Device Record Status

Public Device Record Key: e8f56914-0b4a-42e3-8f6e-08b984376039
Public Version Date: November 23, 2022
Public Version Number: 2
DI Record Publish Date: October 21, 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
07332551992170	10	07332551999759		In Commercial Distribution	PACK_OR_INNER_PACK
07332551992163	6	07332551992170		In Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +46737733775
Email: pedro.lopes@molnlycke.com

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