AccessGUDID - DEVICE: Joseph Lamelas Intercostal Retractor System (IRS) 222 Sterilization Tray (00858733006130)

GUDID

Device Identifier (DI) Information

Brand Name: Joseph Lamelas Intercostal Retractor System (IRS) 222 Sterilization Tray
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MI-IRS-T-22
Company Name: Biorep Technologies, Inc.

Primary DI Number: 00858733006130
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 Intercostal Retractor System product is a reusable thoracotomy retractor system. The individual accessory components include a retractor rack, 4 different sized paired blade set options, 2 different sized double swivel blade options and a custom sterilization tray.

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:	No
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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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: 304234bb-571d-4797-841a-8a21472c901d
Public Version Date: May 01, 2024
Public Version Number: 1
DI Record Publish Date: April 23, 2024