AccessGUDID - DEVICE: Eclypse Adherent Sacral (05060031473940)

GUDID

Device Identifier (DI) Information

Brand Name: Eclypse Adherent Sacral
Version or Model: CR3985
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BRIGHTWAKE LIMITED

Primary DI Number: 05060031473940
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 226502201 *Terms of Use

Device Description: Superabsorbent sacral dressing with Silfix soft silicone contact layer, 17cm X 19cm. Eclypse Adherent Sacral is an exudate management wound dressing especially designed for the sacral area. The dressing combines a Silfix soft silicone contact layer, a rapid wicking layer, a CrystaLock layer, which is highly absorbent and locks away exudate, a sub-backing layer for even exudate distribution and a non-strikethrough backing to prevent leakage.

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?
43186	Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.	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
Width: 17 Centimeter
Length: 19 Centimeter

Device Record Status

Public Device Record Key: 4fd8414c-bf87-41b8-ba61-67257b9e6100
Public Version Date: August 04, 2023
Public Version Number: 1
DI Record Publish Date: July 27, 2023