FDA.reportPublic FDA data

NA

Primary DI
00840085276965
Brand
NA
Company
Astura Medical
Model
MZA080000
Catalog number
MZA080000
Device description
TLIF RETRACTOR, MEDIAL BLADE INSERTER
Published
2025-12-01
Public version status
New
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085276965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085276965008400852769658400852769650840085276965

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, reusableA dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.

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
Premarket exempt
true
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
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775585Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775592Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775608Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775615Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775622Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775639Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775646Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775653Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775660Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775677Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775684Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775691Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775707Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775714Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776872Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776889Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776896Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776902Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27