FDA UDI In Commercial Distribution 🇺🇸 United States

SURGISTAR

DI: 00878799005298 · Model: 2400 · SURGISTAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
SURGISTAR
Primary DI
00878799005298
Version / Model
2400
Company Name
SURGISTAR, INC.
Labeler DUNS
808865125
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-06-08
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6eb4c440-8467-4955-a557-a26088e0b0cb

Device Characteristics

Single Use
Yes
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
No
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
No

Product Codes

Code Name
GDX Scalpel, One-Piece

GMDN Terms

Code Name
44722 Keratome blade, single-use

Identifiers

Type ID
Package 10878799005295
Primary 00878799005298

Customer Contacts

Phone
17605982480