FDA.reportPublic FDA data

Spetzler MacroVac®

Primary DI
00650551142355
Brand
Spetzler MacroVac®
Company
PMT CORPORATION
Model
3201-09M-09-97-PF
Catalog number
3201-09M-09-97-PF
Device description
MEDIUM TIP WITH 90° BEND SOUTH, POLISHED FINISH
Published
2018-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551142355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551142355006505511423556505511423550650551142355

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9French
Length9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
800-626-5463info@pmtcorp.com
800-626-5463intl@pmtcorp.com

Regulatory Flags#

DUNS number
039576871
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006701PMT CORPORATION - STEREOTACTIC2103-15-20-NS2026-06-09
00650551006718PMT CORPORATION - STEREOTACTIC2103-15-25-NS2026-06-09
00650551006725PMT CORPORATION - STEREOTACTIC2103-15-30-NS2026-06-09
00650551006732PMT CORPORATION - STEREOTACTIC2103-15-35-NS2026-06-09
00650551006749DEPTHALON®2102-09-195-NS2026-06-09
00650551006633CORTAC®2110-04-0832026-06-04
00650551006640CORTAC®2110-08-1442026-06-04
00650551006657CORTAC®2110-16-1362026-06-04
00650551006664CORTAC®2110-20-1172026-06-04
00650551006671CORTAC®2110-32-1432026-06-04
00650551006688CORTAC®2110-48-1122026-06-04
00650551006695CORTAC®2110-64-1702026-06-04
00650551006602PMT CORPORATION2127-16-01-088-QDC2026-06-01
00650551006619PMT CORPORATION2127-16-01-089-QDC2026-06-01
00650551006626PMT CORPORATION2127-16-01-090-QDC2026-06-01
00650551006596INTEGRA3610-638-2I-ST62026-05-27
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

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Primary DI, Brand, Company table
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