DEVICE: OSSEOUS Salivary by Pass Tube (08906039312133)

Device Identifier (DI) Information

OSSEOUS Salivary by Pass Tube
E31412W
In Commercial Distribution

EON MEDITECH PRIVATE LIMITED
08906039312133
GS1

1
930270428 *Terms of Use
"Salivary by-pass Tube directs saliva which discharges from neck wound after surgery into the distal esophagus and to facilitate the management of fistula resulting from a variety of causes including advanced malignancy, surgery, radiation, trauma and caustic ingestion.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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?
43684 Polymeric oesophageal stent, non-bioabsorbable
A sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to temporarily maintain luminal patency in strictures and achalasia, seal fistulas, and/or to treat other lesions (e.g., anastomotic leaks). It is a mesh structure, which may or may not be covered/lined, and is made entirely of a synthetic polymer(s) (e.g., silicone). It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KCF Dilator, Esophageal, Ent
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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
Storage Environment Temperature: less than 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 24 Millimeter
Length: 188 Millimeter
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Device Record Status

cc9f6b2f-9f8e-4d82-a4f4-a3bfa17f04e5
July 12, 2024
1
July 04, 2024
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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
08906039314281 1 08906039312133 In Commercial Distribution Laminated Box
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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