AccessGUDID - DEVICE: Design Options® (04046964317910)

GUDID

Device Identifier (DI) Information

Brand Name: Design Options®
Version or Model: 560123
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 560123
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964317910
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Spinal Tray

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
OFU	Spinal anesthesia kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gauge spinal needle : 24

Device Record Status

Public Device Record Key: c9259bb2-0f7a-4e2b-a09d-8c41656fb6e7
Public Version Date: June 16, 2020
Public Version Number: 5
DI Record Publish Date: September 23, 2016