AccessGUDID - DEVICE: INTEGUSEAL (05036912001625)

GUDID

Device Identifier (DI) Information

Brand Name: INTEGUSEAL
Version or Model: 33737
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED

Primary DI Number: 05036912001625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 236059171 *Terms of Use

Device Description: IS200

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?
46700	Surgical skin microbial sealant	A sterile synthetic substance (e.g., cyanoacrylate) intended to be applied to the skin of a patient prior to surgical incision (typically over commonly used preoperative skin preparation and with or without standard surgical draping) to, upon polymerization, bond to the skin and fix microbes, reducing the risk of skin flora contamination during the surgical procedure. It is typically contained within a disposable, ready-to-use applicator. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZP	Sealant, Microbial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052870	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: e4b79790-abf8-451c-8c25-6131bd7d87ee
Public Version Date: December 04, 2024
Public Version Number: 1
DI Record Publish Date: November 26, 2024