DEVICE: Technical Products (B0515006S480)
Device Identifier (DI) Information
Technical Products
500-6S48
In Commercial Distribution
TECHNICAL PRODUCTS INC
500-6S48
In Commercial Distribution
TECHNICAL PRODUCTS INC
silicone sheet sterile
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? |
---|---|---|---|---|
61557 | Silicone-sheet tissue reconstructive material |
A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTL | Mesh, Surgical, Polymeric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K971472 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: .030"x4"x8" |
Device Record Status
624e2e66-71d2-4daa-b4e3-d902aeabfd82
February 05, 2024
4
September 15, 2016
February 05, 2024
4
September 15, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined