DEVICE: Design Options® (04046964318696)

Device Identifier (DI) Information

Design Options®
560451
Not in Commercial Distribution
560451
B. BRAUN MEDICAL INC.
04046964318696
GS1
May 21, 2022
10
002397347 *Terms of Use
Spinal Tray
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34845 Intrathecal anaesthesia set, non-medicated
A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes a spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OFU Spinal anesthesia kit
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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
Handling Environment Temperature: between 1 and 40 Degrees Celsius
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Gauge spinal needle : 22
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Device Record Status

28cbf0cc-0f2e-4f69-ba4d-038a8be8b2b3
May 24, 2022
6
September 23, 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: 04046964318672 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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