AccessGUDID - DEVICE: Design Options® (04046955057009)

GUDID

Device Identifier (DI) Information

Brand Name: Design Options®
Version or Model: 560653
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 560653
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955057009
Issuing Agency: GS1
Commercial Distribution End Date: December 21, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: SSK STEWARD HEALTH CARE SYSTEM

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
Handling Environment Temperature: between 1 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Gauge spinal needle : 22

Device Record Status

Public Device Record Key: f5fd4c6e-4e5b-4194-bdfe-e60554c190c3
Public Version Date: December 27, 2021
Public Version Number: 5
DI Record Publish Date: June 11, 2018