AccessGUDID - DEVICE: V. Mueller (10885403051746)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: HY21320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY21320
Company Name: STERIS CORPORATION

Primary DI Number: 10885403051746
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: PUDENDAL AND PARASYMPATHETIC BLOCK ANESTHESIA NEEDLE 18GA OVERALL LENGTH 6 inches15.2CM

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?
62984	Cervical anaesthesia needle, reusable	A sharp bevel-edged, hollow tubular metal instrument intended to be used to administer an analgesic or anaesthetic agent to function as an intracervical nerve-block and/or a paracervical regional nerve-block (sometimes including uterosacral and pudendal regions). It is typically used for gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. It typically includes connectors for attachment to the piston of a syringe or intravascular administration set. This is a reusable device intended to be sterilized prior to use.	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: dac2b797-d597-4717-8320-cf3f8afc8ccf
Public Version Date: August 19, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016