FDA.reportPublic FDA data

Spetzler MacroVac®

Primary DI
00650551137634
Brand
Spetzler MacroVac®
Company
PMT CORPORATION
Model
3201-05S-4.5-SF
Catalog number
3201-05S-4.5-SF
Device description
SLOTTED TIP, SATIN FINISH
Published
2018-11-06
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

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
00650551137634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551137634006505511376346505511376340650551137634

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 Gauge5French

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

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

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
00650551005445CORTAC®2110-06-0052110-06-0052025-04-25
00650551005452CORTAC®2110-08-0062025-04-25
00650551005469CORTAC®2110TX-16-0082025-04-25
00650551005476CORTAC®2110-32-0052025-04-25
00650551005391INTEGRA®3610ES-72-2I-ST2025-03-26
00650551002086PMT® SUCTION INSTRUMENTS9001-06-2252025-03-19
00650551002093PMT® SUCTION INSTRUMENTS9002-08-2252025-03-19
00650551002154INTEGRA®3611-204-2I-ST2025-03-19
00650551002161INTEGRA®3612-04-I-1T2025-03-19
00650551002772INTEGRA®3610-76-2I-ST2025-03-19
00650551002833INTEGRA®3612-06R-IR-ST2025-03-19
00650551002932ALLURA®3321-214-T2025-03-19
00650551002963INTEGRA®3612-61A-IR-ST72025-03-19
00650551003083INTEGRA®3610-23-32025-03-19
00650551003090INTEGRA®3611-674-32025-03-19
00650551003168INTEGRA®3611ES-12-IR-ST2025-03-19
00650551003175INTEGRA®3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®3612ES-04R-IR-ST2025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24
00840314238559gSourceGSOURCE LLCJOL2025-11-24
00840314238566gSourceGSOURCE LLCJOL2025-11-24
00840314238573gSourceGSOURCE LLCJOL2025-11-24
00840314238580gSourceGSOURCE LLCJOL2025-11-24
00840314238597gSourceGSOURCE LLCJOL2025-11-24
00840314238603gSourceGSOURCE LLCJOL2025-11-24
00840314238610gSourceGSOURCE LLCJOL2025-11-24
00840314238627gSourceGSOURCE LLCJOL2025-11-24
00840314238634gSourceGSOURCE LLCJOL2025-11-24
00840314238641gSourceGSOURCE LLCJOL2025-11-24
00840314238658gSourceGSOURCE LLCJOL2025-11-24
00840314238665gSourceGSOURCE LLCJOL2025-11-24