FDA.reportPublic FDA data

SIRION

Primary DI
00841379186007
Brand
SIRION
Company
Astura Medical
Model
GZB09AF16
Catalog number
GZB09AF16
Device description
LLIF COBB, ANGLED, HIGH, CAUDAL
Published
2021-07-13
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379186007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379186007008413791860078413791860070841379186007

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
Length16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-814-8047troy@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
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
10889981217204MeridianSeaspine Orthopedics CorporationKWQ2022-08-25
10889981230838RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230845RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230852RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230869RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230876RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230883RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230890RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231040RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231057RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231064RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231071RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231088RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981214289MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214296MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214302MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214319MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214326MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214333MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214340MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214357MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214364MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214371MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214388MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214524MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214531MeridianSeaspine Orthopedics CorporationKWQ2020-12-30