FDA UDI In Commercial Distribution 🇺🇸 United States

SURJEX

DI: G383KILLIANNASALSPECUM7 · Model: WM4612075, WM4612090, WM4612035 · SURJEX
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SURJEX
Primary DI
G383KILLIANNASALSPECUM7
Version / Model
WM4612075, WM4612090, WM4612035
Catalog Number
WM4612075, WM4612090, WM4612035
Company Name
SURJEX
Labeler DUNS
645518882
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-31
Public Version
1
Public Version Date
2024-04-08
Public Version Status
New
Public Device Record Key
ccd80854-c2fb-42c4-b081-9c732289525f

Device Description

Killian Nasal Speculum 6" 50mm Blade With Set Screw Killian Nasal Specula 5" 75mm---3"Blade With Set Screw Killian Nasal Spectula 5" 90mm Blade With Set Screw Killian Nasal Specula 5" 35mm Blade With Set Screw

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
EPY Speculum, Ent

GMDN Terms

Code Name
35350 Nasal speculum, reusable

Identifiers

Type ID
Primary G383KILLIANNASALSPECUM7