FDA UDI In Commercial Distribution 🇺🇸 United States

MR PHACO

DI: G412PH6498L0 · Model: PH6498L · Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MR PHACO
Primary DI
G412PH6498L0
Version / Model
PH6498L
Company Name
Crestpoint Management Limited
Labeler DUNS
836285668
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-06-03
Public Version
1
Public Version Date
2025-06-11
Public Version Status
New
Public Device Record Key
b61d0a1f-c529-45d9-a9b1-1472c1c91a46

Device Description

Koch Spatula and Karate Chopper DBL-Ended, Koch Spatula, .8mm Wide Gently Curved Shaft with Duckbill-Shaped tip / Katate Chopper with 1mm long cutting wedge for use in the LEFT hand, Angled 10mm from bend to tip, Round Knurled Handle, 126mm 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
HNQ Hook, Ophthalmic

GMDN Terms

Code Name
42595 Soft-tissue surgical hook, reusable

Identifiers

Type ID
Primary G412PH6498L0