AccessGUDID - DEVICE: Spetzler

GUDID

Device Identifier (DI) Information

Brand Name: Spetzler - OMT
Version or Model: Neuro Patties
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALL
Company Name: OMT, LLC

Primary DI Number: M731100010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 196899772 *Terms of Use

Device Description: Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
32572	Cottonoid pad	A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HBA	Neurosurgical Paddie

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020736	000

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
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity
Storage Environment Temperature: between 30 and 70 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 591f42ac-7679-4bd2-bda2-e80d85839d63
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 24, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
M7311100169	5	M731100010	In Commercial Distribution	Box
M7311100159	10	M731100010	In Commercial Distribution	Box
M7311100189	3	M731100010	In Commercial Distribution	Box