AccessGUDID - DEVICE: Integra® (10381780264064)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: PISGLL10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA PAIN MANAGEMENT

Primary DI Number: 10381780264064
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 030370299 *Terms of Use

Device Description: 10CC GLASS L.O.R. (LUER LOCK)

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:	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?
44057	General surgical procedure kit, medicated	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 CC

Device Record Status

Public Device Record Key: 4950d24d-aabf-42a2-89bf-b6237b289680
Public Version Date: April 05, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 2016