FDA.report

PMT® Suction Instruments

Primary DI
00650551101352
Brand
PMT® Suction Instruments
Company
PMT CORPORATION
Model
9002-09-145T
Catalog number
9002-09-145T
Device description
MALLEABLE SURGICAL SUCTION, TEARDROP TIP
Published
2018-02-12
Public version status
Update
Distribution status
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
00650551101352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551101352006505511013526505511013520650551101352

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
Catheter Gauge9French

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature58 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods

Method
Hydrogen Peroxide

Contacts

PhoneEmail
800-626-5463info@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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