AccessGUDID - DEVICE: Lateral Patient Positioning System (00190376471303)

GUDID

Device Identifier (DI) Information

Brand Name: Lateral Patient Positioning System
Version or Model: 180-600-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALPHATEC SPINE, INC.

Primary DI Number: 00190376471303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 602465783 *Terms of Use

Device Description: Loading Base B

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):	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?
31684	Operating table patient pressure distribution pad, reusable	A cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	SUPPORT, PATIENT POSITION

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 5c9b01a8-b40d-4c1d-a1f7-41b4527d3317
Public Version Date: February 16, 2023
Public Version Number: 2
DI Record Publish Date: September 27, 2022