AccessGUDID - DEVICE: ArmGuard™ (20811836030437)

GUDID

Device Identifier (DI) Information

Brand Name: ArmGuard™
Version or Model: 40206
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dan Allen Surgical LLC

Primary DI Number: 20811836030437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 040876183 *Terms of Use

Device Description: ArmGuard Width Extender Packs - Each Pack contains: Two Width Extender Pads for table mattresses up to 3 in | 7.6 cm. Case of 12 ea. 00811836030433 (model #40203)

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?
65157	Operating table mattress extension pad	A cushioned pad intended to increase the surface area of an operating table mattress upon which the patient is placed. It is attached to the operating table (e.g., table rails, patient restraint anchor) and is typically used to extend the mattress width to support a bariatric patient’s arms during a surgical procedure. 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: e943e1ee-7352-452e-b452-7cb8e5e0859e
Public Version Date: October 24, 2022
Public Version Number: 3
DI Record Publish Date: May 17, 2021