FDA.report

FacetBRIDGE

Primary DI
03662663024327
Brand
FacetBRIDGE
Company
LDR Spine Usa, Inc.
Model
FS9081R
Catalog number
FS9081R
Published
2018-12-12
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
HXXScrewdriver

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663024327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663024327036626630243273662663024327

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
true
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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03662663059183Mobi-C Plug & Fit USMB9176R2024-01-15
03662663059145Mobi-C Plug & Fit USMB9100R2024-01-12
03662663059152Mobi-C Plug & Fit USMB9101R2024-01-12
03662663000215Mobi-CMB900RMB900R2018-12-12
03662663000222Mobi-CMB903RMB903R2018-12-13
03662663000239Mobi-CMB904RMB904R2018-12-12
03662663000246Mobi-CMB906RMB906R2018-12-12
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663000376Mobi-CMB943RMB943R2018-12-13
03662663000383Mobi-CMB944RMB944R2018-12-13
03662663000390Mobi-CMB945RMB945R2018-12-13
03662663000406Mobi-CMB946RMB946R2018-12-13
03662663000413Mobi-CMB947RMB947R2018-12-13
03662663000420Mobi-CMB948RMB948R2018-12-13
03662663000437Mobi-CMB949RMB949R2018-12-13
03662663000819Mobi-C® Plug & Fit USMB9008R2014-09-24
03662663000826Mobi-C® Plug & Fit USMB9009R2014-09-24
03662663000833Mobi-C® Plug & Fit USMB9010R2014-09-24

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