AccessGUDID - DEVICE: SuperClip Securement Clasp (10815614020606)

GUDID

Device Identifier (DI) Information

Brand Name: SuperClip Securement Clasp
Version or Model: 4600-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 140-0600-30
Company Name: Semler Technologies, Inc.

Primary DI Number: 10815614020606
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042075700 *Terms of Use

Device Description: The SuperClip is a sterile, single-use clip that can be used to secure drapes, guidewires or catheters during a vascular access or other cannulation procedure. Ridges on the ergonomically curved handle enables secure manipulation, and elastomeric pads provide a secure grip on drapes, wires, and catheters. The Model 4600-30 is green in color.

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:	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?
66742	Surgical drape clip, single-use	A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGZ	Accessories, Catheter

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: c03e6b45-91e7-47fc-a98c-15b98dd765e4
Public Version Date: October 16, 2024
Public Version Number: 5
DI Record Publish Date: June 30, 2017