AccessGUDID - DEVICE: HK Sterile Super Absorbent Pads Small (00816989020805)

GUDID

Device Identifier (DI) Information

Brand Name: HK Sterile Super Absorbent Pads Small
Version or Model: SPD-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SPD-S
Company Name: HK SURGICAL INC.

Primary DI Number: 00816989020805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 106885259 *Terms of Use

Device Description: HK Sterile Super Absorbent Pads Small

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?
58805	Absorbent wound compression pad	A rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. This is a single-use device.	Active	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: 3c740c3b-6ef3-4cb5-b7c3-5b7716725d22
Public Version Date: July 07, 2020
Public Version Number: 3
DI Record Publish Date: December 22, 2017