AccessGUDID - DEVICE: ENVI (H965355020)

GUDID

Device Identifier (DI) Information

Brand Name: ENVI
Version or Model: 35-502
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NAVILYST MEDICAL, INC.

Primary DI Number: H965355020
Issuing Agency: HIBCC
Commercial Distribution End Date: June 03, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 809699023 *Terms of Use

Device Description: GUIDEWIRE 0.018 X 65CM Ti/Tu

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	CATHETER, IRRIGATION
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170775	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
Length: 65 Centimeter
Outer Diameter: 0.018 Inch

Device Record Status

Public Device Record Key: e6c7d657-8271-4df3-88f8-557a7fe988bc
Public Version Date: March 20, 2024
Public Version Number: 8
DI Record Publish Date: August 07, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H965355021	5	H965355020	2019-06-03	Not in Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
GS1	15051684023559

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

[?]

Phone: +1(518)795-1676
Email: dgreer@angiodynamics.com

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