AccessGUDID - DEVICE: Integra® (10381780262206)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: 3404892
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA PAIN MANAGEMENT

Primary DI Number: 10381780262206
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 030370299 *Terms of Use

Device Description: DNA TRAY FOR USE IN SPINAL CORD STIM TRIAL

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
12404	Lumbar puncture kit	A collection of devices intended for transient percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to obtain a sample of cerebrospinal fluid (CSF). Typical components include a spinal needle and collection tubes for the CSF; a drainage catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

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
Special Storage Condition, Specify: Storage Environment Temperature: 20 C to 25 C (68 F to 77 F)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3aa4c658-795b-44f1-b5ff-48112f197102
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: September 16, 2016