FDA.report

Design Options®

Primary DI
04046964319990
Brand
Design Options®
Company
B. BRAUN MEDICAL INC.
Model
560572
Catalog number
560572
Device description
Spinal Tray
Published
2016-09-23
Public version status
Update
Distribution status
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
04046964319990PrimaryGS10
04046964319976Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964319990040469643199904046964319990
04046964319976040469643199764046964319976

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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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