AccessGUDID - DEVICE: Pak-its® (10381780491880)

GUDID

Device Identifier (DI) Information

Brand Name: Pak-its®
Version or Model: 59145
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DUP59145
Company Name: Derma Sciences Canada Inc

Primary DI Number: 10381780491880
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: 0.25 in X 5 yards gauze packing iodoform strip in bottles with dispenser insert.

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?
48129	Gauze strip, antimicrobial	A thin length of woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FER	Anoscope and accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 0.63 cm X 4.5 m
Device Size Text, specify: 0.25 in X 5 yards

Device Record Status

Public Device Record Key: 55a9944e-1add-4e0f-8ba1-630f92951165
Public Version Date: June 25, 2024
Public Version Number: 4
DI Record Publish Date: October 23, 2018