AccessGUDID - DEVICE: Elset® (05055158001503)

GUDID

Device Identifier (DI) Information

Brand Name: Elset®
Version or Model: 3482
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mölnlycke Health Care AB

Primary DI Number: 05055158001503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631770658 *Terms of Use

Device Description: Elset 10cm x 6m x 12

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
63279	Pressure bandage, Hevea-latex, reusable	A strip or roll made of fabric which includes Hevea natural rubber latex (NRL) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema), and may in addition be intended for dressing retention. The latex component is intended to create a bandage that clings to itself more than to skin so that compression can be maintained over longer periods. It is intended for use in the home or healthcare facility. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	BANDAGE, ELASTIC

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6m

Device Record Status

Public Device Record Key: 57985e18-59fe-4928-b46f-86679fde3de4
Public Version Date: November 09, 2023
Public Version Number: 1
DI Record Publish Date: November 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07332551976958	5	05055158001831		In Commercial Distribution	CASE
05055158001831	12	05055158001503		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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