AccessGUDID - DEVICE: HK Sterile Super Absorbent OR Table Sheet 31"x 48" (00816989020843)

GUDID

Device Identifier (DI) Information

Brand Name: HK Sterile Super Absorbent OR Table Sheet 31"x 48"
Version or Model: SPD-OR3148
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SPD-OR3148
Company Name: HK SURGICAL INC.

Primary DI Number: 00816989020843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 106885259 *Terms of Use

Device Description: HK Sterile Super Absorbent OR Table Sheet 31"x 48"

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?
61849	Absorbent underpad, sterile	A sterile flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	Fiber, Medical, Absorbent

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 8bbd306b-498b-436a-9101-6c27915a919c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 22, 2017