AccessGUDID - DEVICE: Medline Industries, Inc. (10889942160358)

GUDID

Device Identifier (DI) Information

Brand Name: Medline Industries, Inc.
Version or Model: DYND04155
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYND04155
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10889942160358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: BOZEMAN UTERINE FORCEP

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:	Yes
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?
57977	Hysterectomy forceps, single-use	A sterile, hand-held, manual surgical instrument intended for the grasping, pulling or compression of the uterus during a hysterectomy (for the removal of the womb and the necessary associated organs). It typically has a scissors-like, self-retaining, design with ring handles and is made of high-grade plastic. It is available in various sizes and the working end can have a variety of blade designs, e.g., straight or curved. The distal ends of the blades are heavily serrated to provide extra grip of the organ. It is also known as a vaginal clamp or Cheron forceps. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OFF	Central venous catheter tray

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2da9bb93-5d24-49d7-a961-8de2057dffab
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 07, 2016