FDA.reportPublic FDA data

GET IMPLANT

Primary DI
07290109743035
Brand
GET IMPLANT
Company
BHI IMPLANTS LTD
Model
1
Catalog number
GIH-2300
Device description
Torque/Ratchet
Published
2022-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109743035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109743035072901097430357290109743035

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+972046094458info@bh-implants.com

Regulatory Flags#

DUNS number
600330916
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109747941Parallel Pin 1GIH-20002026-04-05
07290109747958Parallel Pin 1GIH-20012026-04-05
07290109747965Hand Hex Drive1GIH-HD2M2026-04-05
07290109747972Hand Hex Drive1GIH-HD2L2026-04-05
07290109747989Motor Mount1GIH-MK2L2026-04-05
07290109747996Motor Mount1GIH-MK2S2026-04-05
07290109748016Hand Hex Drive1GIH-HD1L2026-04-05
07290109748023Hand Hex Drive1GIH-HD1S2026-04-05
07290109748030Motor Mount1GIH-1MKL2026-04-05
07290109748047Motor Mount1GIH-1MKS2026-04-05
07290109747934Bhi Implants1BH-NMUSS2026-01-20
07290109747781OsseoPress®1RS-OPD2252026-01-08
07290109747798OsseoPress®1RS-OPD2502026-01-08
07290109747804OsseoPress®1RS-OPD2752026-01-08
07290109747811OsseoPress®1RS-OPD3002026-01-08
07290109747828OsseoPress®1RS-OPD3252026-01-08
07290109747835OsseoPress®1RS-OPD3502026-01-08
07290109747842OsseoPress®1RS-OPD3752026-01-08
07290109747859OsseoPress®1RS-OPD4002026-01-08
07290109747866OsseoPress®1RS-OPD4252026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08