FDA UDI In Commercial Distribution 🇺🇸 United States

GemcisionTM Angled Paracentesis, Super Sharp, Sharp Sides, 1.2mm Width/Box of 5

DI: 20840096201332 · Model: 7924-P12-60Ab · KATALYST SURGICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
GemcisionTM Angled Paracentesis, Super Sharp, Sharp Sides, 1.2mm Width/Box of 5
Primary DI
20840096201332
Version / Model
7924-P12-60Ab
Company Name
KATALYST SURGICAL LLC
Labeler DUNS
007883297
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-07
Public Version
1
Public Version Date
2023-06-15
Public Version Status
New
Public Device Record Key
7f41d518-b409-4af6-8216-b0466e055ec0

Device Description

GemcisionTM Angled Paracentesis, Super Sharp, Sharp Sides, 1.2mm Width/Box of 5

Device Characteristics

Single Use
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
HNN Knife, Ophthalmic

GMDN Terms

Code Name
32764 Ophthalmic knife, reusable

Identifiers

Type ID
Primary 20840096201332