AccessGUDID - DEVICE: DELTAFILL (10886704077169)

GUDID

Device Identifier (DI) Information

Brand Name: DELTAFILL
Version or Model: DLF182060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DLF182060
Company Name: Medos International Sàrl

Primary DI Number: 10886704077169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: DELTAFILL Microcoil 18 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: DELTAFILL 18 Stretch Resistant Coil 20mm (coil diameter) x 60cm (coil length) 190cm (working length)

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?
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; 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
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: a07237a7-9f4a-412b-80db-4537a33436e3
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: November 16, 2016