FDA.reportPublic FDA data

OLYMPIC

Primary DI
00841379161790
Brand
OLYMPIC
Company
Astura Medical
Model
EBEEJAAZA
Catalog number
EBEEJAAZA
Device description
T-HANDLE, L, AO, TORQUE, STAINLESS STEEL CORE, INTERNAL, NON-CANNULATED, 26.5 IN-LBS
Published
2021-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379161790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379161790008413791617908413791617900841379161790

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047TROY@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840085244919OLYMPICAZC010030AZC0100302026-04-15
00840085252761OLYMPICAZC170000AZC1700002026-04-15
00840085213120SIRIONGZC11D10AGZC11D10A2021-07-15
00841379186588SIRIONGZB13AE02GZB13AE022021-07-13
00840085201585SIRIONGZA150000GZA1500002021-07-12
00840085278518ALTANBT095060NBT0950602026-02-03
00840085277603ALTANBF045025NBF0450252026-02-02
00840085278051ALTANBF095060NBF0950602026-02-02
00840085278068ALTANBT045025NBT0450252026-02-02
00840085219641EL CAPITANKZB100000KZB1000002021-07-30
00840085233500DOLOMITELZA040000LZA0400002021-07-27
00840085233517DOLOMITELZA050000LZA0500002021-07-27
00840085233524DOLOMITELZA060000LZA0600002021-07-27
00840085235078DOLOMITELZB040000LZB0400002021-07-27
00840085235085DOLOMITELZB050000LZB0500002021-07-27
00840085236938DOLOMITELZD020000LZD0200002021-07-27
00840085236990DOLOMITELZD060000LZD0600002021-07-27
00840085242274DOLOMITELZD070000LZD0700002021-07-27
00840085272271ASYNJABB00025JABB000252024-01-09
00840085272288ASYNJABB00050JABB000502024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606187565Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187572Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187589Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187596Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187602Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187619Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606187633Ventana ASPINAL ELEMENTS, INC.OVD2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.OVD2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24