FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551001912 · Model: 204812 · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
n.a.
Primary DI
04048551001912
Version / Model
204812
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
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
512f74fe-89f1-4c42-b6c4-7ab9ff300123

Device Description

Suction Tube, 12 Fr.

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code Name
EOX ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

GMDN Terms

Code Name
10217 Surgical suction system

Identifiers

Type ID
Primary 04048551001912

Premarket Submissions

Submission Number Supplement Number
K945237 000