AccessGUDID - DEVICE: Surge Cardiovascular (00817278010033)

GUDID

Device Identifier (DI) Information

Brand Name: Surge Cardiovascular
Version or Model: 213-010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213-010
Company Name: Med Michigan Holdings, LLC

Primary DI Number: 00817278010033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097462979 *Terms of Use

Device Description: Suture Guide, Single Pack

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?
13895	Operative-site suture holder	A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEJ	Carrier, Ligature

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 [?]
Ethylene Oxide

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: d1cb743e-f51c-498f-8aa1-befe39b758cf
Public Version Date: September 21, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016