DEVICE: NA (04546540600950)

Device Identifier (DI) Information

NA
0700020000
Not in Commercial Distribution
0700-020-000
STRYKER CORPORATION
04546540600950
GS1
March 25, 2021
1
196548481 *Terms of Use
Standard 4-Port Manifold
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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. 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?
47998 Surgical fluid/smoke waste management system
An assembly of devices designed to collect and dispose of both surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a mains electricity (AC-powered) mobile suction unit and a fixed disposal unit. The suction unit uses negative pressure at the site of intervention to collect/filter the fluid/smoke in its containers and filters; it is attached to the disposal unit for automatic container emptying and cleaning. The system is used in the operating room (OR), pathology and surgical centres, and doctor's offices to minimize healthcare worker exposure to harmful fluids/smoke.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FYD APPARATUS, EXHAUST, SURGICAL
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

5a85bb69-6ef9-4bda-852f-72e451fa9e75
August 30, 2021
3
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
34546540600951 10 04546540600950 2021-03-25 Not 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
No
No
No CLOSE

Customer Contact

[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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