AccessGUDID - DEVICE: TrenGuard™ (10811836030140)

GUDID

Device Identifier (DI) Information

Brand Name: TrenGuard™
Version or Model: 55401
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dan Allen Surgical LLC

Primary DI Number: 10811836030140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 040876183 *Terms of Use

Device Description: TrenGuard 450 HYBRID Wedge Packs - Each 4-piece Pack contains: Wedge "Speed Bump" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 204 kg. Case of 12 ea. 00811836030143 (model #55461)

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?
65178	Operating table patient positioning set, single-use	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 patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use 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: 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: a3da31bb-e63e-4ac4-bf9b-b86ffcf0a201
Public Version Date: October 24, 2022
Public Version Number: 3
DI Record Publish Date: May 17, 2021