FDA UDI In Commercial Distribution 🇺🇸 United States

Not Applicable

DI: 18904233120148 · Model: #STITCH CUTTER · NIRAJ INDUSTRIES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100

Basic Information

Brand Name
Not Applicable
Primary DI
18904233120148
Version / Model
#STITCH CUTTER
Catalog Number
02014
Company Name
NIRAJ INDUSTRIES PRIVATE LIMITED
Labeler DUNS
650191174
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-07-01
Public Version
3
Public Version Date
2021-01-22
Public Version Status
Update
Public Device Record Key
f6af39c2-b39c-4765-b18e-c82b8f01dc58

Device Description

CARBON STEEL STERILE SURGICAL BLADE #STITCH CUTTER WITH SILICON COATING INDIVIDUALLY PACKED MYCO REORDER # 2002-SC

Device Characteristics

Single Use
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GES Blade, Scalpel

GMDN Terms

Code Name
37445 Manual scalpel blade, single-use

Identifiers

Type ID
Package 28904233120145
Primary 18904233120148
Package 58904233120146
Unit of Use 08904233120141