DEVICE: Valleylab (10884524001944)

Device Identifier (DI) Information

Valleylab
E2771-45
Not in Commercial Distribution

Covidien LP
10884524001944
GS1
July 18, 2025
1
058614483 *Terms of Use
Laparoscopic Curved Spatula Electrode,Solid
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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?
58039 Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904560 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Length: 45 Centimeter
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Device Record Status

84a3a3cb-aff0-4b34-a0fe-73ddda784a3c
July 23, 2025
14
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30884524001948 25 20884524001941 2025-07-18 Not in Commercial Distribution CASE
20884524001941 10 10884524001944 2025-07-18 Not in Commercial Distribution PACK_OR_INNER_PACK
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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