FDA UDI In Commercial Distribution 🇺🇸 United States

n.a.

DI: 04048551155455 · Model: 37112VS · Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
n.a.
Primary DI
04048551155455
Version / Model
37112VS
Company Name
Karl Storz GmbH & Co. KG
Labeler DUNS
315731430
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
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
99fd75cd-6d0b-4049-aff1-1f3036e355da

Device Description

Sealing Ball, package of 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
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
GCJ Laparoscope, general & plastic surgery

GMDN Terms

Code Name
10217 Surgical suction system

Identifiers

Type ID
Primary 04048551155455
Unit of Use 04048551254356

Premarket Submissions

Submission Number Supplement Number
K945059 000