FDA.reportPublic FDA data

OLYMPIC

Primary DI
00841379165590
Brand
OLYMPIC
Company
Astura Medical
Model
AZE120085
Catalog number
AZE120085
Device description
MIS CORTICAL BONE TAP,
Published
2021-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
LXHOrthopedic Manual Surgical Instrument
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379165590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379165590008413791655908413791655900841379165590

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@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
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00197157119638ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119645ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119652ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119669ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119676ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119683ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119690ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119706ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119713ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119720ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119737ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119744ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119751ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119768ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119775ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119782ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119799ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119805ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119812ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119829ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119836ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119843ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119850ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119867ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119874ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119881ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119898ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119904ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119911ZAVATION SCREWZavation LLCNKB2026-10-12