MABIS DMI

Basic Information

• Brand Name: MABIS DMI
• Primary DI: 10767056092355
• Version / Model: D 9235
• Catalog Number: D 9235
• Company Name: D-M-S HOLDINGS, INC.
• Labeler DUNS: 062028220
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2023-05-18
• Public Version Status: Update
• Public Device Record Key: b6033637-d505-45f4-9aab-073cb42afc25
• Distribution End Date: 2023-05-17

Device Description

PLASTIBELL PHYSICIAN BULK 1.5CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FHG	Bell, Circumcision	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38523	Surgical penis clamp, single-use	A sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10767056092355	GS1