AccessGUDID - DEVICE: Invotec Silicone Sheeting (00818501021901)

GUDID

Device Identifier (DI) Information

Brand Name: Invotec Silicone Sheeting
Version or Model: 20-20685B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-20685B
Company Name: INVOTEC INTERNATIONAL, INC.

Primary DI Number: 00818501021901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622812592 *Terms of Use

Device Description: Silicone Sheeting, Blue, 15cm X 11.5cm X 0.13mm (6.0" X 4.5" X 0.005")

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):	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?
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 42d50792-0144-4d71-ba0b-d96f920371c3
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022