FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528114322
Brand
OsteoMed
Company
OSTEOMED LLC
Model
114-1651
Catalog number
114-1651
Device description
1.6MM DRIVER STEM W/POST, AO SHNK, MED
Published
2018-10-26
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
GXLSCREWDRIVER, SKULLPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528114322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528114322008425281143228425281143220842528114322

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845694011815OsteoMed375-0008375-00082016-07-21
00845694041546OsteoMed320-2701320-27012016-07-21
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610733850365OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850372OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850464OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850556OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850563OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850617OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
06903195298570Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
06903195298587Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
04056481145606HEX SCREWDRIVER T-HANDLE (2.5 MM)Brainlab SEGXL2023-10-19
00888233048361SEEG LONG BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00888233048378SEEG SHORT BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00856482008467KLS E-Coupling AdapterPRO-DEX, INC.GXL2023-05-23
04056481144708Skull Reference Screwdriver HandleBrainlab SEGXL2023-05-05
04056481144715Skull Reference Screwdriver BladeBrainlab SEGXL2023-05-05
G28435301ScrewdriverNeurovention LLCGXL2022-06-21
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PRO-DEX, INC.GXL2022-04-01
00856482008269MatrixPRO II Handpiece LoanerPRO-DEX, INC.GXL2022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPRO-DEX, INC.GXL2022-04-01
00860540000225MatrixPRO Driver LoanerPRO-DEX, INC.GXL2022-04-01
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEPRO-DEX, INC.GXL2022-03-29
00862377000140BATTERY PACK, KLS-SD-1000, SINGLEPRO-DEX, INC.GXL2022-03-29
00856482008016KLS E-Coupling AdapterPRO-DEX, INC.GXL2022-03-29
00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29