AccessGUDID - DEVICE: Merocel® (20681490105785)

GUDID

Device Identifier (DI) Information

Brand Name: Merocel®
Version or Model: 400903
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 20681490105785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: PACKING 400903 5PK FEMORAL CANAL 20CM

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):	Yes
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?
36226	Cavity-wound management dressing, non-antimicrobial	A non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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
Length: 20.0 Centimeter

Device Record Status

Public Device Record Key: c453a7d1-0158-4c46-a7e5-0977fff6ceff
Public Version Date: March 01, 2021
Public Version Number: 5
DI Record Publish Date: September 09, 2017