AccessGUDID - DEVICE: Concerto Detachable Coil System (00763000307240)

GUDID

Device Identifier (DI) Information

Brand Name: Concerto Detachable Coil System
Version or Model: NV-10-20-HELIX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Micro Therapeutics, Inc.

Primary DI Number: 00763000307240
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 826110710 *Terms of Use

Device Description: COIL NV-10-20-HELIX V07

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?
60941	Non-neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090046	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
Storage Environment Temperature: less than 50 Degrees Celsius
Special Storage Condition, Specify: store in a cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df1a9e7f-fa4f-4b6f-b991-93c2d08ee77a
Public Version Date: September 25, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2020