AccessGUDID - DEVICE: TOTALSHIELD® (00889024376465)

GUDID

Device Identifier (DI) Information

Brand Name: TOTALSHIELD®
Version or Model: 00-9900-312-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-9900-312-10
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024376465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: Zippered Surgical Toga, XL

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):	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?
35102	Surgical helmet system	A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	GOWN, SURGICAL

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: XL

Device Record Status

Public Device Record Key: 110bd5a3-59ed-48bb-8713-dc4ab1f4fc49
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 07, 2017