AccessGUDID - DEVICE: Mesalt® (07323190293100)

GUDID

Device Identifier (DI) Information

Brand Name: Mesalt®
Version or Model: 285580
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mölnlycke Health Care AB

Primary DI Number: 07323190293100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631770658 *Terms of Use

Device Description: Mesalt 5x5cm

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?
58475	Sodium chloride dressing	A sterile material impregnated or saturated with sodium chloride (NaCl) or sodium chloride-based solutions (e.g., Ringer’s) intended to be applied to a skin wound to facilitate wound cleansing and healing by absorbing exudates and infectious/necrotic materials from the wound through osmotic action. It is available in various forms (e.g., non-woven material square/rectangle, ribbon) for application to superficial or deep wounds. It is normally used in a healthcare facility or in homecare. 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: 5cm x 5cm

Device Record Status

Public Device Record Key: dc01f1a1-f4e7-451a-bffb-46943b51bc69
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
07323190233137	8	07323190233144		In Commercial Distribution	CASE
07323190233144	30	07323190293100		In Commercial Distribution	PACK_OR_INNER_PACK

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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