AccessGUDID - DEVICE: V. Mueller (10885403046742)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GL5150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GL5150
Company Name: CAREFUSION 2200, INC

Primary DI Number: 10885403046742
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 832696038 *Terms of Use

Device Description: V. Mueller PARACERVICAL AND PUDENDAL NERVE BLOCK NEEDLE OVERALL LENGTH 8" (20.3CM) RETRACTED

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
61547	Peripheral nerve-block sharp needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, hypodermic, single lumen

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2e2a81a-8830-4cef-89a3-2b9a555b192b
Public Version Date: March 07, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016