FDA.reportPublic FDA data

SPETZLER MACROVAC®

Primary DI
00650551004509
Brand
SPETZLER MACROVAC®
Company
PMT CORPORATION
Model
3201-07T-09-095-PF
Device description
MACROVAC 7 FRENCH, 9 INCH LENGTH, TEARDROP TIP, WITH 90 DEGREE BEND NORTH, POLISHED FINISHED
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00650551004509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551004509006505510045096505510045090650551004509

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;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006572DEPTHALON®2102-06-005-NS2026-05-26
00650551006589DEPTHALON®2102-06-0052026-05-26
00650551005537DEPTHALON®2104-04-32-0012026-05-18
00650551005865MICROMAT®3105-M-B-122026-05-18
00650551005872MICROMAT®3105-M-Y-122026-05-18
00650551006022INTEGRA3610-76-ST2026-05-18
00650551006039INTEGRA3610-76-2-ST2026-05-18
00650551006046INTEGRA3611-690-2-ST2026-05-18
00650551006060INTEGRA3610-636-3-ST2026-05-18
00650551006077INTEGRA3611-230-2-ST2026-05-18
00650551006084INTEGRA3614-42-2-ST2026-05-18
00650551006091INTERCONNECTION CABLE2127-12-01-087-QDC2026-05-18
00650551006114CORTAC®2110-64-1692026-05-18
00650551006138DEPTHALON®2102-02-1912026-05-18
00650551006145INTERCONNECTION CABLE2127-16-04-Y92026-05-18
00650551006176INTEGRA3614-14-2-IR2026-05-18
00650551006220INTERCONNECTION CABLE2120-10-0102026-05-18
00650551006237INTEGRA3611-691-IR-ST2026-05-18
00650551006459INTERCONNECTION CABLE2120-16-01-0112026-05-18
00650551006480INTERCONNECTION CABLE2127-16-04-Y10-NS2026-05-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10381780185604Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
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10381780185680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185697Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27