FDA.report

Curved Tip Elevator, Straight Handle, 185mm

Primary DI
00856312006854
Brand
Curved Tip Elevator, Straight Handle, 185mm
Company
KATALYST SURGICAL LLC
Model
N2502
Device description
Each, Periosteal Elevator, Straight, 185mm
Published
2016-06-29
Public version status
Update
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
HTEElevator

Product Code Classifications

CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00856312006854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00856312006854008563120068548563120068540856312006854

GMDN Terms

TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
007883297
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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