DEVICE: TEACHING MIRROR (00192896071513)

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Device Record History
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Device Identifier (DI) Information
TEACHING MIRROR
C-000.33.209
In Commercial Distribution
C-000.33.209
SONTEC INSTRUMENTS, INC.
00192896071513
GS1

1
040729840 *Terms of Use
HEINE OMEGA 500 BINO OPHTHALMOSCOPE TRAINING MIRROR
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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?
32261 General/plastic surgery mirror
A reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FTX MIRROR, GENERAL & PLASTIC SURGERY
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Dry Heat Sterilization
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
0b71703b-5cee-49f2-bd70-b0f9e188d6fc
April 24, 2025
2
September 17, 2018
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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

[?]
+1(800) 821-7496
info@sontecinstruments.com
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