FDA UDI In Commercial Distribution 🇺🇸 United States

Oertli®

DI: 07630003915709 · Model: VV621011DEC · Oertli-Instrumente AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Oertli®
Primary DI
07630003915709
Version / Model
VV621011DEC
Company Name
Oertli-Instrumente AG
Labeler DUNS
481505238
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-15
Public Version
1
Public Version Date
2024-10-23
Public Version Status
New
Public Device Record Key
31e6da89-9d55-479b-8ff3-cdf4c15a21e9

Device Description

PHACO PACK FAROS/CR3/SWISSTECH; SLEEVE (FOR EASYTIP 2.2MM),; TEST CHAMBER, TUBING SYSTEM

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HQC Unit, Phacofragmentation

GMDN Terms

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

Identifiers

Type ID
Package 07630003915716
Primary 07630003915709