DEVICE: Hex Handle Tip Sucker W/Vent (B0662012800000)

Device Identifier (DI) Information

Hex Handle Tip Sucker W/Vent
201280-000
In Commercial Distribution
201280-000
NOVOSCI CORP.
B0662012800000
HIBCC

1
938289980 *Terms of Use
A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical irrigation/aspiration handpiece, single-use A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8b2769e6-2c0f-43a5-b636-11c9a3b09f1a
March 29, 2018
2
September 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B0662012800006 100 B0662012800000 In Commercial Distribution Case
B0662012800005 75 B0662012800000 In Commercial Distribution Partial Case
B0662012800004 50 B0662012800000 In Commercial Distribution Partial Case
B0662012800003 25 B0662012800000 In Commercial Distribution Inner Case
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Secondary DI

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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