FDA.reportPublic FDA data

SIRION

Primary DI
00840085201356
Brand
SIRION
Company
Astura Medical
Model
GZB230618
Catalog number
GZB230618
Device description
DISTRACTOR
Published
2021-07-15
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
00840085201356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085201356008400852013568400852013560840085201356

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Width6Millimeter

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
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.KWQ2026-07-23
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