AccessGUDID - DEVICE: MECRON Thorax Women B: 14,5 cm, U: 72-98 cm (00609271951402)

GUDID

Device Identifier (DI) Information

Brand Name: MECRON Thorax Women B: 14,5 cm, U: 72-98 cm
Version or Model: 38-7520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38-7520
Company Name: DARCO INTERNATIONAL, INC.

Primary DI Number: 00609271951402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184231298 *Terms of Use

Device Description: M

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?
47217	Abdominal binder, reusable	A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPX	ORTHOSIS, RIB FRACTURE, SOFT

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
No Device Sizes

Device Record Status

Public Device Record Key: 496d609a-b28f-41bc-9e44-b5b04034bb75
Public Version Date: February 22, 2023
Public Version Number: 1
DI Record Publish Date: February 14, 2023