FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551048658 · Model: 10438 · 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
04048551048658
Version / Model
10438
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
f879791f-d9f8-4cd9-8297-9676f4ab435a

Device Description

Anspirat.Biopsy Needle,transtrach

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

Product Codes

Code Name
EOX ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

GMDN Terms

Code Name
38824 General-purpose endoscopic needle, reusable

Identifiers

Type ID
Primary 04048551048658

Premarket Submissions

Submission Number Supplement Number
K945237 000