FDA UDI In Commercial Distribution 🇺🇸 United States

SILVER SCOPE

DI: 04048551003633 · Model: 13821NKS · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SILVER SCOPE
Primary DI
04048551003633
Version / Model
13821NKS
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
5
Public Version Date
2024-10-21
Public Version Status
Update
Public Device Record Key
df216697-de8a-453d-922d-eb9e09c45038

Device Description

Gastroscope 9.3/2.8/1100 NTSC

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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide, Peracetic Acid, Liquid Chemical, Hydrogen Peroxide

Product Codes

Code Name
FDS Gastroscope and accessories, flexible/rigid

GMDN Terms

Code Name
17663 Flexible video gastroscope, reusable

Identifiers

Type ID
Primary 04048551003633