DEVICE: Bariatric Table Extensions, Full Set of 8 with 2" Pads, 24" Leg Section (00810105030228)

Device Identifier (DI) Information

Bariatric Table Extensions, Full Set of 8 with 2" Pads, 24" Leg Section
3-2001-001
In Commercial Distribution
OZ 7557175
COMPOSITE MANUFACTURING, INC.
00810105030228
GS1

1
947090650 *Terms of Use
Modular, radiolucent carbon fiber surgical table width extenders for accommodating bariatric patients
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
65180 Operating table patient positioning set, reusable
A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BWN Table And Attachments, Operating-Room
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d70e2c8-4d3a-4d36-8950-a07ee1acaf90
June 22, 2021
1
June 14, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
9493617580
info@carbonfiber.com
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