DEVICE: n.a. (04048551083970)

Device Identifier (DI) Information

n.a.
24941HTS
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551083970
GS1

1
315731430 *Terms of Use
Anal Dilator, ø 30 mm, 15 cm
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
Rectal dilator, reusable A surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GCF PROCTOSCOPE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K945209 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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

1b2b7958-bb3e-4257-973b-c1cc32d75235
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE