AccessGUDID - DEVICE: Pediatric sternum retractor, infant (10817121000584)

GUDID

Device Identifier (DI) Information

Brand Name: Pediatric sternum retractor, infant
Version or Model: 1100210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100210
Company Name: Coroneo Inc

Primary DI Number: 10817121000584
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 255276362 *Terms of Use

Device Description: Pediatric sternum retractor for the infant patient, comprises two spreader arms and one pinion.

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:	Yes
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: 2823471b-ce84-470b-980c-e22d87c5aa6f
Public Version Date: February 09, 2024
Public Version Number: 1
DI Record Publish Date: February 01, 2024