FDA.report

ROI-C

Primary DI
03662663047395
Brand
ROI-C
Company
LDR Spine Usa, Inc.
Model
SI-ROIC-0112
Catalog number
SI-ROIC-0112
Device description
Small Depth Stop
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663047395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663047395036626630473953662663047395

GMDN Terms

TermDefinition
Orthopaedic implant/instrument depth limiterAn orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implant below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-699-3360custserv@ldrspine.com

Regulatory Flags

DUNS number
615789729
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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03662663000437Mobi-CMB949RMB949R2018-12-13
03662663000819Mobi-C® Plug & Fit USMB9008R2014-09-24
03662663000826Mobi-C® Plug & Fit USMB9009R2014-09-24
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