DEVICE: KnifeLight (34546540060113)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
KnifeLight
3300-001-000
In Commercial Distribution
3300-001-000
Stryker GmbH
34546540060113
GS1

10
481999654 *Terms of Use
KNIFE LIGHT 10,PK
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
58783 Hand ligament surgical release instrument
A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FTD Lamp, surgical
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 40 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Height: 102.0 Millimeter
Width: 292.0 Millimeter
Length: 305.0 Millimeter
CLOSE

Device Record Status
0309ad11-37f3-465e-a3ff-59540561554e
April 14, 2025
7
September 24, 2015
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: 04546540060112 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE