AccessGUDID - DEVICE: IMPEDE Embolization Plug (B054IMP071)

GUDID

Device Identifier (DI) Information

Brand Name: IMPEDE Embolization Plug
Version or Model: IMP-07
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IMP-07
Company Name: SHAPE MEMORY MEDICAL INC

Primary DI Number: B054IMP071
Issuing Agency: HIBCC
Commercial Distribution End Date: March 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 025984823 *Terms of Use

Device Description: IMPEDE Embolization Plug 7mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
46852	Extraluminal vascular occluder, single-use	A device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, For Promoting Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181051	000

Device Exempt from Premarket Submission: No 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: 33febc94-accb-4516-9d57-517af29d63c6
Public Version Date: April 08, 2022
Public Version Number: 4
DI Record Publish Date: October 31, 2019