AccessGUDID - DEVICE: Biotronik BioEnvelope (04035479160548)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronik BioEnvelope
Version or Model: 440578
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Elutia Med LLC

Primary DI Number: 04035479160548
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080924060 *Terms of Use

Device Description: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35273	Cardiovascular patch, animal-derived	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 9.5 Centimeter
Height: 6.9 Centimeter

Device Record Status

Public Device Record Key: 13aff85c-ddbb-4f83-8bdc-e1950a32459f
Public Version Date: September 24, 2024
Public Version Number: 3
DI Record Publish Date: August 26, 2019