BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

OIC Lumbar Interbody Cages

DI: M696380000 · Model: 380-00 · ORTHOPAEDIC IMPLANT COMPANY, THE

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: OIC Lumbar Interbody Cages
Primary DI: M696380000
Version / Model: 380-00
Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
Labeler DUNS: 070061160
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-02-01
Public Version: 5
Public Version Date: 2022-06-10
Public Version Status: Update
Public Device Record Key: b5f18bce-381a-4279-bd9d-dd063edce636

Device Description

RASP DOUBLE SIDED

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
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: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35559	Bone file/rasp, manual, reusable	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M696380000	HIBCC

Customer Contacts

Phone: 775 636 8281
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K082260	000