FDA.report

Design Options®

Primary DI
04046964807206
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
560643
Catalog number
560643
Device description
Spinal Tray
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OFUSpinal anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964807206PrimaryGS10
04046964807190Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964807206040469648072064046964807206
04046964807190040469648071904046964807190

GMDN Terms

TermDefinition
Intrathecal anaesthesia set, non-medicatedA 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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50198956266511CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
04046955672028Design Options®B. BRAUN MEDICAL INC.OFU2025-12-22
04046961012641Design Options®B. BRAUN MEDICAL INC.OFU2025-08-31
50198956169591CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
50198956133691CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
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50198956080650CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
04046955672004Design Options®B. BRAUN MEDICAL INC.OFU2025-04-27
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