AccessGUDID - DEVICE: Neptune ® Comfort Band with Calcium Alginate Wound Dressing (10811331010166)

GUDID

Device Identifier (DI) Information

Brand Name: Neptune ® Comfort Band with Calcium Alginate Wound Dressing
Version or Model: CB-8517N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tz Medical, Inc.

Primary DI Number: 10811331010166
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 793149709 *Terms of Use

Device Description: Neptune ® Comfort Band with Calcium Alginate Wound Dressing 17 inch Sterile

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?
34084	Wound compression dressing	A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040208	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 018ffb6a-9220-4576-b564-babec1532dfc
Public Version Date: October 24, 2023
Public Version Number: 1
DI Record Publish Date: October 16, 2023