AccessGUDID - DEVICE: Integra® (10381780431312)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: CUS526
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CUS526
Company Name: INTEGRA PAIN MANAGEMENT

Primary DI Number: 10381780431312
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: 10381780263678

Device Description: Biopsy 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?
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. 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 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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: 97feb6dc-f2d4-4665-9ec6-95958db24d45
Public Version Date: December 05, 2023
Public Version Number: 2
DI Record Publish Date: June 20, 2018