AccessGUDID - DEVICE: BioPatch® (10381780112204)

GUDID

Device Identifier (DI) Information

Brand Name: BioPatch®
Version or Model: INS400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INS400
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780112204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Evolution™ Pole Mount Assembly with cm H2O and mm Hg Rail with Laser Level and Line Level

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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?
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062599	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31227aba-379c-4303-ad52-fa898b1ee6d1
Public Version Date: May 16, 2023
Public Version Number: 8
DI Record Publish Date: September 22, 2015