FDA.report

BioHorizons

Primary DI
00847236011079
Brand
BioHorizons
Company
BIOHORIZONS IMPLANT SYSTEMS, INC
Model
TBIDH
Device description
HD Implant-level Driver, Handpiece, 5.7mm
Published
2016-04-04
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

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847236020200Direct MarkingGS10
00847236011079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847236020200008472360202008472360202000847236020200
00847236011079008472360110798472360110790847236011079

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

Regulatory Flags

DUNS number
967279910
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00847236027797BioHorizonsCNTE0TCNTE0T2026-02-26
00847236027803BioHorizonsCNTE2TCNTE2T2026-02-26
00847236027810BioHorizonsCNTE3SCNTE3S2026-02-26
00847236027827BioHorizonsCNTE3TCNTE3T2026-02-26
00847236027834BioHorizonsCNTE4SCNTE4S2026-02-26
00847236027841BioHorizonsCNTE4TCNTE4T2026-02-26
00847236027858BioHorizonsCNTEA3CNTEA32026-02-26
00847236027865BioHorizonsCNTEA4CNTEA42026-02-26
00847236027872BioHorizonsCNTNA3CNTNA32026-02-26
00847236027889BioHorizonsCNTNA4CNTNA42026-02-26
00847236027896BioHorizonsCRTE3SCRTE3S2026-02-26
00847236027902BioHorizonsCRTE3TCRTE3T2026-02-26
00847236027919BioHorizonsCRTE4SCRTE4S2026-02-26
00847236027926BioHorizonsCRTE4TCRTE4T2026-02-26
00847236027933BioHorizonsCRTEA3CRTEA32026-02-26
00847236027940BioHorizonsCRTEA4CRTEA42026-02-26
00847236027957BioHorizonsCRTNA3CRTNA32026-02-26
00847236027964BioHorizonsCRTNA4CRTNA42026-02-26
00847236027421BioHorizonsPXMUPSDPXMUPSD2025-06-12
00847236027438BioHorizonsPXMUPSD25PXMUPSD252025-06-12

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