DEVICE: INFILTRATION TUBING (B089B892161)

Device Identifier (DI) Information

INFILTRATION TUBING
B89216
In Commercial Distribution
B89216
BLACK & BLACK SURGICAL, INC.
B089B892161
HIBCC

10
004382282 *Terms of Use
15' LARGE BORE TUBING W/SILICONE INSERT FOR INFILTRATION PUMP SYSTEMS -SINGLE SPIKE, BOX OF 10
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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
Surgical irrigation/aspiration tubing set A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GAZ Tubing, Noninvasive
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FDA Premarket Submission

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

Sterilization

Yes
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

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Size Type Text
No Device Sizes
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Device Record Status

60561ced-3802-4d1a-949f-6ec0b4a80fae
March 29, 2018
2
August 19, 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

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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: B089B892160 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8772522517
info@blackandblacksurgical.com
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