AccessGUDID - DEVICE: VENTERA (00817470009521)

GUDID

Device Identifier (DI) Information

Brand Name: VENTERA
Version or Model: 420-20111
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 420-20111
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00817470009521
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: VENTERA CANNULATED INSTRUMENT; ORANGE

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:	No
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?
35253	Paranasal sinus probe	A hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LCR	FLUORESCENT IMMUNOASSAY, TOBRAMYCIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121351	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: ad5bd84a-402b-416f-8f35-b2a081e44d34
Public Version Date: September 07, 2023
Public Version Number: 6
DI Record Publish Date: December 06, 2015