DEVICE: N/A (00885825013288)

Device Identifier (DI) Information

N/A
N/A
In Commercial Distribution
5DCS
STRYKER SUSTAINABILITY SOLUTIONS, INC.
00885825013288
GS1

1
020198912 *Terms of Use
Endopath Curved Scissors w/Unipolar Cautery
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical 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 may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, probe with controls) and requires a patient contact return electrode to complete the circuit. This is a previously used single-use device that has been processed for an additional single-use patient application.
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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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -22 and 60 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter: 5.0 Millimeter
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Device Record Status

d2987238-2e82-4488-853e-f5c1125f17db
March 29, 2018
2
September 23, 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
30885825013289 6 00885825013288 In Commercial Distribution 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(888)888-3433
RegulatoryAffairs2@stryker.com
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