AccessGUDID - DEVICE: V. Mueller (10885403046834)

GUDID

Device Identifier (DI) Information

Brand Name: V. Mueller
Version or Model: GL5320-4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GL53204
Company Name: STERIS CORPORATION

Primary DI Number: 10885403046834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021599373 *Terms of Use

Device Description: V. Mueller DE LEE OBSTETRICAL FORCEPS 1 PAIR DELICATE OVERALL LENGTH 12 inches 30.5CM

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?
35082	Obstetrical forceps, reusable	A scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDA	Forceps, obstetrical

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: 31e6d335-1a00-4915-87a7-e8f03949cb63
Public Version Date: August 19, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016