DEVICE: M-Flex® (00816734020258)

Device Identifier (DI) Information

M-Flex®
1207-24
In Commercial Distribution
1207-24
DIVERSATEK HEALTHCARE, INC.
00816734020258
GS1

1
030650113 *Terms of Use
Blue Silicone Tungsten Hurst Esophageal Dilator, 24 French
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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?
35052 Oesophageal bougie, reusable
A cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store flat, do not hang
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 24 French
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Device Record Status

1305b023-4f26-4272-aefd-3803691d102f
April 10, 2019
7
September 17, 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

[?]
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
Yes
No
No CLOSE

Customer Contact

[?]
800-558-6408
sales@diversatekhc.com
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