FDA UDI In Commercial Distribution 🇺🇸 United States

Not Applicable

DI: 18904233117414 · Model: #15 · NIRAJ INDUSTRIES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25

Basic Information

Brand Name
Not Applicable
Primary DI
18904233117414
Version / Model
#15
Catalog Number
01741
Company Name
NIRAJ INDUSTRIES PRIVATE LIMITED
Labeler DUNS
650191174
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2020-07-01
Public Version
1
Public Version Date
2020-07-09
Public Version Status
New
Public Device Record Key
b4bf4eaa-e441-4f53-b779-bdae8b151403

Device Description

STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #15 BULK PACKED MYCO REORDER # 6000CST-15

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
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
GES Blade, Scalpel

GMDN Terms

Code Name
47569 Scalpel, single-use

Identifiers

Type ID
Package 28904233117411
Primary 18904233117414
Package 58904233117412
Unit of Use 08904233117417