DEVICE: n.a. (04048551405130)

Device Identifier (DI) Information

n.a.
28163TB
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551405130
GS1

1
315731430 *Terms of Use
Operating Cannula, ø 4.5 mm
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General-purpose endoscopic needle, reusable A flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HRX ARTHROSCOPE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K943154 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
Ethylene Oxide
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

89077c1c-c854-4e3a-9516-732ef452530e
July 06, 2018
3
September 23, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE