DEVICE: BELLOW WITH VENTIL AND CONNECTION (B0990411020100)

Device Identifier (DI) Information

BELLOW WITH VENTIL AND CONNECTION
04-11020-10
Not in Commercial Distribution

SONTEC INSTRUMENTS, INC.
B0990411020100
HIBCC
September 20, 2018
1
040729840 *Terms of Use
BELLOW BLUE WITH VENTIL AND CONNECTION M8
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33466 ENT powder applicator
An applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HET Laparoscope, Gynecologic (And Accessories)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002877 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

b281c18c-8db3-44b1-942f-55e613fe9556
September 20, 2018
5
September 30, 2017
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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

[?]
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

[?]
303-790-9411
info@sontecinstruments.com
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