AccessGUDID - DEVICE: Stimuplex® (04046964767258)

GUDID

Device Identifier (DI) Information

Brand Name: Stimuplex®
Version or Model: 332135
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 332135
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964767258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Single Shot Nerve Block Tray (Kit) with 22 Ga. x 2 in. Stimuplex® Ultra 360® Insulated Echogenic Needle and Ultrasound Transducer Cover and Gel (SNB200U3)

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?
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction 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 (cannula) : 22

Device Record Status

Public Device Record Key: f711b00f-80af-4527-98df-599bb5f12fed
Public Version Date: January 08, 2021
Public Version Number: 9
DI Record Publish Date: September 23, 2016