FDA.reportPublic FDA data

GEO Single Use Driver Handle

Primary DI
B471201800000
Brand
GEO Single Use Driver Handle
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
20180000
Device description
Driver Handle Hudson Fixed Straight Single Use
Published
2020-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B471201800000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, single-useA sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)436-2278GEOSupportCenter@gramercyortho.com

Regulatory Flags#

DUNS number
080068420
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B471120301040Lapidus Plating System120301042023-07-17
B471120302050Lapidus Plating System120302052023-07-17
B471120303050Lapidus Plating System120303052023-07-17
B471123301040Lapidus Plating System123301042023-07-17
B471123302050Lapidus Plating System123302052023-07-17
B471123303050Lapidus Plating System123303052023-07-17
B471126300040Lapidus Plating System126300042023-07-17
B471126600050Distal Fibula Plating System126600052022-01-10
B471126600070Distal Fibula Plating System126600072022-01-10
B471126600090Distal Fibula Plating System126600092022-01-10
B471126600110Distal Fibula Plating System126600112022-01-10
B471126601050Distal Fibula Plating System126601052022-01-10
B471126601070Distal Fibula Plating System126601072022-01-10
B471126601090Distal Fibula Plating System126601092022-01-10
B471126601110Distal Fibula Plating System126601112022-01-10
B471120200000FirstFUSE 1st MTP Joint Plating System120200002020-10-23
B471120200050FirstFUSE 1st MTP Joint Plating System120200052020-10-23
B471120200500FirstFUSE 1st MTP Joint Plating System120200502020-10-23
B471120200550FirstFUSE 1st MTP Joint Plating System120200552020-10-23
B471120201000FirstFUSE 1st MTP Joint Plating System120201002020-10-23

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Primary DI, Brand, Company table
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00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
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B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03