AccessGUDID - DEVICE: ABS HOOK AND LOOP PAD (00842430115455)

GUDID

Device Identifier (DI) Information

Brand Name: ABS HOOK AND LOOP PAD
Version or Model: 160-0011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 600-0016
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430115455
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use
Previous DI: 00869284000225

Device Description: No description.

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":	Yes
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?
58986	Multi-purpose surgical skin adhesive tape	A long thin band of synthetic material coated on one or both sides with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or a combination of materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORC	Air Filter Portable Apparatus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123006	000

Device Exempt from Premarket Submission: No 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: fc6b859a-3fee-4107-9b25-07df3294b186
Public Version Date: July 21, 2025
Public Version Number: 9
DI Record Publish Date: February 19, 2021