AccessGUDID - DEVICE: Penumbra Coil 400 (00815948025103)

GUDID

Device Identifier (DI) Information

Brand Name: Penumbra Coil 400
Version or Model: 4002C1545-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4002C1545
Company Name: PENUMBRA, INC.

Primary DI Number: 00815948025103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191077671 *Terms of Use

Device Description: Coil 400 Standard, 15mm x 45cm

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":	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?
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
60491	Surgical microscope video camera, sterilizable	An optical device intended to be used as part of a video camera surgical microscope system to send magnified images of a surgical site, via a camera and appropriate hardware, to a monitor to facilitate visualization of the surgical site by the surgeon or for teaching applications. It is typically a housing containing a distal lens, fibreoptic cabling, and an illumination port. It is intended to be fixed (using a positioning arm) at an appropriate distance from the surgical site (e.g., 25-75cm), and is not intended to contact the patient. This is a reusable device intended to be sterilized prior to use.	Active	false

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 [?]
K173614	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: 5c634d13-2676-4fb9-9f70-0944dd394f71
Public Version Date: March 15, 2023
Public Version Number: 1
DI Record Publish Date: March 07, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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