FDA.reportPublic FDA data

Spetzler MacroVac®

Primary DI
00650551149118
Brand
Spetzler MacroVac®
Company
PMT CORPORATION
Model
3201-09-ST
Device description
"STYLET FOR MALLEABLE SURGICAL SUCTION INSTRUMENT, 9"" LENGTH, SET OF 5"
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551149118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551149118006505511491186505511491180650551149118

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration handpiece, reusableA hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
039576871
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10650551093616NEW BEGINNINGS® GEL SHEETING3505-12025-03-19
10650551093623NEW BEGINNINGS® GELSHAPES®3505-102025-03-19
10650551093630NEW BEGINNINGS® GELSHAPES®3505-112025-03-19
10650551093647NEW BEGINNINGS® GELSHAPES®3505-122025-03-19
10650551093654NEW BEGINNINGS® GELSHAPES®3505-22025-03-19
10650551093661NEW BEGINNINGS® GELSHAPES®3505-32025-03-19
10650551093678NEW BEGINNINGS® GELSHAPES®3505-42025-03-19
10650551093685NEW BEGINNINGS® GELSHAPES®3505-52025-03-19
10650551093692NEW BEGINNINGS® GELSHAPES®3505-82025-03-19
20650551093613NEW BEGINNINGS® GEL SHEETING3505-1-62025-03-19
20650551093620NEW BEGINNINGS® GELSHAPES®3505-10-62025-03-19
00650551006978PMT® SUCTION INSTRUMENTS9002-07-100-ST2026-07-20
00650551006992CORTAC®2110-08-1452026-07-20
00650551006794ILSO™1515-08SF2026-07-18
00650551006800ILSO™1515-08MF2026-07-17
00650551006817ILSO™1515-08LF2026-07-17
00650551006824ILSO™1515-08XF2026-07-17
00650551006831ILSO™1515-08SM2026-07-17
00650551006848ILSO™1515-08MM2026-07-17
00650551006855ILSO™1515-08LM2026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995293581V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
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00724995293604V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293611V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306281V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306298V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306304V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00190776424121MillenniumAvalign Technologies, Inc.GZX2026-08-27
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00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20