CER-RMR-11

Basic Information

• Brand Name: CER-RMR-11
• Primary DI: 00850023741127
• Version / Model: 11GA X 8.4"
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 3
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 01103ff5-7703-4f85-8f5c-86173f91b967

Device Description

Cervos 11GA Reamers P/N: 74371-01M Customer #: 12153

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
HTO	Reamer	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61807	Bone-resection orthopaedic reamer, single-use	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850023741124	GS1	Inner pack	1	In Commercial Distribution
Primary	00850023741127	GS1
Package	20850023741121	GS1	Case	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	8.4	Inch
Outer Diameter	.097	Inch