DEVICE: n.a. (04048551048122)
Device Identifier (DI) Information
n.a.
10385AL
In Commercial Distribution
Karl Storz GmbH & Co. KG
10385AL
In Commercial Distribution
Karl Storz GmbH & Co. KG
Sponge Holder, work. length 55 cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11791 | Dressing/utility forceps, scissors-like, reusable |
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K943700 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Peracetic Acid |
Hydrogen Peroxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1ae762bc-2319-4cf1-ac56-819ac8ed329a
August 21, 2019
4
September 23, 2016
August 21, 2019
4
September 23, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined