DEVICE: NA (04055207023242)

Device Identifier (DI) Information

NA
8964041
In Commercial Distribution
8964.041
Richard Wolf GmbH
04055207023242
GS1

1
315304071 *Terms of Use
AMPLATZ SHEATH FOR NEPHROSCOPE 24.3FR SL 150mm, round, fixed irrigation tap, distal end straight, compatible with nephroscopes to 24Fr, reusable
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Rigid endoscope sheath, reusable A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FED endoscopic access overtube, gastroenterology-urology
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K994223 000
No CLOSE

Sterilization

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

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 8.1 Millimeter
CLOSE

Device Record Status

f6d07f60-5528-4744-b719-9badb3107913
July 24, 2018
4
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
CLOSE