AccessGUDID - DEVICE: RTI (00843059119510)

GUDID

Device Identifier (DI) Information

Brand Name: RTI
Version or Model: 19-DILATOR-13
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TEDAN SURGICAL INNOVATIONS, L.L.C.

Primary DI Number: 00843059119510
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 791619393 *Terms of Use

Device Description: CLARITY DILATOR #2, 13MM

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):	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?
11268	Vascular dilator, reusable	A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 1b2ab7ca-b386-48a7-b459-a8affd9f04de
Public Version Date: June 15, 2023
Public Version Number: 4
DI Record Publish Date: December 25, 2017