DEVICE: NA (10888551010061)

Device Identifier (DI) Information

NA
ETH5DCD
In Commercial Distribution
ETH5DCD
STERILMED, INC.
10888551010061
GS1

1
175899459 *Terms of Use
DISSECTOR CURVED WITH UNIPOLAR CAUTERY
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61875 Endoscopic electrosurgical electrode, monopolar, single-use
A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NUJ ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012598 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6bcdfef9-b412-4813-b5c8-fd02166c0eae
August 14, 2019
4
September 22, 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
No Package DIs found
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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(888)541-0078
sterilmedcs@its.jnj.com
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