FDA UDI In Commercial Distribution 🇺🇸 United States

CONSTELLATION® HYPERVIT® TOTAL PLUS®

DI: 00380658300777 · Model: 8065830077 · Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
CONSTELLATION® HYPERVIT® TOTAL PLUS®
Primary DI
00380658300777
Version / Model
8065830077
Company Name
Alcon Laboratories, Inc.
Labeler DUNS
008018525
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-11
Public Version
2
Public Version Date
2022-01-24
Public Version Status
Update
Public Device Record Key
2dd2be25-937b-4d93-af22-425b2db7b84a

Device Description

25+®Ga HYPERVIT® Bevel 20K CPM Wide TOTAL PLUS® Vitrectomy Pak

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MLZ Vitrectomy, instrument cutter

GMDN Terms

Code Name
45150 Ophthalmic surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Package 10380658300774
Primary 00380658300777