AccessGUDID - DEVICE: Integra® (10381780033301)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: 901212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780033301
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Integra 31 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in the bullet-shaped tip and a stainless steel handle. The introducer is designed to be used with a sheath (inner diameter: 4 mm) to make a subcutaneous tunnel between two incisions for the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. When ordering additional sheaths, specify Catalog No. 990012 (31cm).

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":	Yes
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?
46800	Subcutaneous tunneller, reusable	A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIY	Stainless steel instrument, shunt system implantation

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
Device Size Text, specify: 31cm Length

Device Record Status

Public Device Record Key: 1476de08-5e36-465f-96d6-580781ab42aa
Public Version Date: February 09, 2023
Public Version Number: 3
DI Record Publish Date: August 12, 2016