AccessGUDID - DEVICE: JOSEPH LAMELAS Atrial Lift System (00858733006017)

GUDID

Device Identifier (DI) Information

Brand Name: JOSEPH LAMELAS Atrial Lift System
Version or Model: 10.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MI-ALS-001
Company Name: Biorep Technologies, Inc.

Primary DI Number: 00858733006017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073724333 *Terms of Use

Device Description: The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.

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?
57992	Atrial retractor	A sterile, self-expanding, manual surgical device designed to separate the edges of a left atrium wall incision (atriotomy) so that the mitral valve can be easily accessed during surgery. The device is typically made of a flat polymeric sheet that is bent by the surgeon to form a conical cylinder; the opposing ends are locked together with a sliding mechanism that allows the device to be held together with forceps or a clamp as a compressed cylinder for introduction to the site where it expands once in situ. It is available in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: 4e693e2b-2be3-4edb-a895-05b8286466e8
Public Version Date: May 01, 2024
Public Version Number: 1
DI Record Publish Date: April 23, 2024