AccessGUDID - DEVICE: AVANOS (00193494337377)

GUDID

Device Identifier (DI) Information

Brand Name: AVANOS
Version or Model: 33737
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 33737
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193494337377
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: INTEGUSEAL Microbial Sealant

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:	No
Prescription Use (Rx):	No
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 [?]
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
Area/Surface Area: 1250 Square centimeter

Device Record Status

Public Device Record Key: 519a256f-1b4f-4fdf-b169-d0e1f0506a65
Public Version Date: July 18, 2023
Public Version Number: 2
DI Record Publish Date: July 16, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10193494337374	10	00193494337377	2023-07-12	Not in Commercial Distribution	DSP
20193494337371	2	10193494337374	2023-07-12	Not in Commercial Distribution	CS

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(844)428-2667
Email: PIQ@AVANOS.COM

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