AccessGUDID - DEVICE: RUBY Coil (M424RBY2C04350)

GUDID

Device Identifier (DI) Information

Brand Name: RUBY Coil
Version or Model: RBY2C0435-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PENUMBRA, INC.

Primary DI Number: M424RBY2C04350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191077671 *Terms of Use

Device Description: PC400 Cplx Std, 4x35

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):	No
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?
43980	Embolization implant kit	A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103305	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: aec715bc-8167-4ce5-8077-e094a482d31c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 12, 2016

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
GS1	00814548012889

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: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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