AccessGUDID - DEVICE: Integra® (10381780431589)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: SS3157
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SS3157
Company Name: INTEGRA PAIN MANAGEMENT

Primary DI Number: 10381780431589
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 030370299 *Terms of Use
Previous DI: 10381780265016

Device Description: Prep Tray

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?
35246	Surgical patient preparation kit	A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960248	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c2f431aa-80fa-4ea2-9de7-34768a8fc9eb
Public Version Date: December 05, 2023
Public Version Number: 3
DI Record Publish Date: June 20, 2018