FDA.report

MACROVAC®

Primary DI
00650551027720
Brand
MACROVAC®
Company
PMT CORPORATION
Model
3201-09M-09-PF
Catalog number
3201-09M-09-PF
Device description
MEDIUM TIP, POLISH FINISH
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GZXInstrument, Microsurgical

Product Code Classifications

CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551027720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551027720006505510277206505510277200650551027720

GMDN Terms

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

TypeValueUnit
Length9Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-626-5463intl@pmtcorp.com

Regulatory Flags

DUNS number
039576871
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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00650551003175INTEGRA®3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®3612ES-04R-IR-ST2025-03-19
00650551003205INTEGRA®3610-579-22025-03-19
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