AccessGUDID - DEVICE: Schaerer Medical USA (00810101301049)

GUDID

Device Identifier (DI) Information

Brand Name: Schaerer Medical USA
Version or Model: GS090217B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS090217B
Company Name: Schaerer Medical Usa, Inc.

Primary DI Number: 00810101301049
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092820703 *Terms of Use

Device Description: HEAD SECTION PAD 2"

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:	No
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?
65180	Operating table patient positioning set, reusable	A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FWZ	Operating Room Accessories Table Tray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Height: 2 Inch

Device Record Status

Public Device Record Key: 3feee3bc-4478-4e61-ac8c-2d403b57c1b1
Public Version Date: September 26, 2022
Public Version Number: 1
DI Record Publish Date: September 16, 2022