FDA UDI In Commercial Distribution 🇺🇸 United States

Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing

DI: 00818501022687 · Model: 20-30041RS · INVOTEC INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing
Primary DI
00818501022687
Version / Model
20-30041RS
Catalog Number
20-30041RS
Company Name
INVOTEC INTERNATIONAL, INC.
Labeler DUNS
622812592
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-06
Public Version
1
Public Version Date
2022-12-14
Public Version Status
New
Public Device Record Key
0f6fbe7e-3285-4b54-ba88-7006a3931b79

Device Description

Custom Cut Silicone Sheeting For Internal Nasal Splints & Packing, Reinforced 1.0" X 1.0" X 0.040"

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LYA Splint, Intranasal Septal

GMDN Terms

Code Name
31919 Intranasal splint, non-biodegradable

Identifiers

Type ID
Primary 00818501022687