FDA.report

Aztec

Primary DI
B87110110230
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-11023
Catalog number
10-11023
Device description
Antrum Cannula 4mm short curve
Published
2020-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JZFTube, Ear Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B87110110230PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical irrigation/aspiration cannula, illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It has a built-in light or fibreoptic bundle for illumination. The device may incorporate a handle with side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
117559084
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
true

Other Devices From This Company

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B87110204300Aztec10-2043010-204302022-05-09
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B8711055410Aztec10-55412022-05-09
B87110221100Aztec10-2211010-221102022-02-15
B87111151000Aztec11-1510011-151002020-10-09
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B87111151500Aztec11-1515011-151502020-10-09
B87111152000Aztec11-1520011-152002020-10-09
B87111153000Aztec11-1530011-153002020-10-09
B87111153050Aztec11-1530511-153052020-10-09
B87111153090Aztec11-1530911-153092020-10-09
B87111153200Aztec11-1532011-153202020-10-09
B87111154000Aztec11-1540011-154002020-10-09
B87111155000Aztec11-1550011-155002020-10-09
B87111155100Aztec11-1551011-155102020-10-09
B87111155110Aztec11-1551111-155112020-10-09
B87111155130Aztec11-1551311-155132020-10-09
B87111155150Aztec11-1551511-155152020-10-09

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