FDA UDI In Commercial Distribution 🇺🇸 United States

MR PHACO

DI: G412PH60850 · Model: PH6085 · Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MR PHACO
Primary DI
G412PH60850
Version / Model
PH6085
Company Name
Crestpoint Management Limited
Labeler DUNS
836285668
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-05-27
Public Version
1
Public Version Date
2025-06-04
Public Version Status
New
Public Device Record Key
881b4589-baa6-4c83-9bcf-ff45e0f71d13

Device Description

Castroviejo Lachrymal Dilator DBL/Ended Lachrymal Dilator, Size 1 Fine Taper / Size 2 Medium Taper, Round Knurled Handle, 120mm Overall Length, Stainless Steel

Device Characteristics

Single Use
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HNW Dilator, Lachrymal

GMDN Terms

Code Name
35010 Lacrimal dilator, reusable

Identifiers

Type ID
Primary G412PH60850