FDA UDI In Commercial Distribution 🇺🇸 United States

Blue Silicone Sleeve, Packard 0.7mm and MST Phaco Wrench

DI: 00844685004041 · Model: SPK-0012-1 · MICROSURGICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Blue Silicone Sleeve, Packard 0.7mm and MST Phaco Wrench
Primary DI
00844685004041
Version / Model
SPK-0012-1
Catalog Number
SPK-0012-1
Company Name
MICROSURGICAL TECHNOLOGY, INC.
Labeler DUNS
097824130
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-19
Public Version
4
Public Version Date
2019-10-07
Public Version Status
Update
Public Device Record Key
bce851be-4d56-4058-8513-f4c206f90726

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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Radiation Sterilization"]

Product Codes

Code Name
KYG Device, Irrigation, Ocular Surgery

GMDN Terms

Code Name
17899 Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Identifiers

Type ID
Primary 00844685004041