FDA.report

Aztec

Primary DI
B87110144040
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-14404
Catalog number
10-14404
Device description
Lawson Suction Elevator-Gorney
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
KADElevator, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B87110144040PrimaryHIBCC0

GMDN Terms

TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. 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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B87110221100Aztec10-2211010-221102022-02-15
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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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