DEVICE: N/A (00885825017620)

Device Identifier (DI) Information

N/A
N/A
In Commercial Distribution
LF1637
STRYKER SUSTAINABILITY SOLUTIONS, INC.
00885825017620
GS1

1
020198912 *Terms of Use
Blunt Tip Laparoscopic Sealer/Divider
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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, bipolar, reprocessed A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open 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, rigid probe with controls). 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 -18 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter: 5.0 Millimeter
Length: 37.0 Centimeter
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Device Record Status

02ee3763-8a90-4616-9236-15d029d13b29
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
50885825017625 6 00885825017620 In Commercial Distribution case
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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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