FDA UDI Not in Commercial Distribution 🇺🇸 United States

PAPILLOTOMY KNIFE

DI: 04953170038457 · Model: KD-22Q-1 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2

Basic Information

Brand Name
PAPILLOTOMY KNIFE
Primary DI
04953170038457
Version / Model
KD-22Q-1
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2016-09-21
Public Version
7
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
c92ad33d-2678-4a6a-9518-39c1ae4e4216
Distribution End Date
2022-08-10

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
KNS Unit, electrosurgical, endoscopic (with or without accessories)

GMDN Terms

Code Name
33596 Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Identifiers

Type ID
Package 14953170038454
Primary 04953170038457
Unit of Use 84953170038453

Customer Contacts