AccessGUDID - DEVICE: Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes (B040SRLPAR0)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes
Version or Model: SRLP-AR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRLP-AR
Company Name: GENESEE BIOMEDICAL, INC.

Primary DI Number: B040SRLPAR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939872651 *Terms of Use

Device Description: Large Patient Curved Sternal Latch Retractor with 2 sets of Blades, and Atrial and Aortic Rakes: Suitable for adult patients >90 kg or with BMI of 35 or above

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":	Yes
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?
46771	Sternum spreader	A self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

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: 082392ef-2c68-42ec-ac04-d5a8b2cfa2cc
Public Version Date: December 12, 2024
Public Version Number: 1
DI Record Publish Date: December 04, 2024