FDA.reportPublic FDA data

ALEXANDER-FARABEUF RASPATORY

Primary DI
00192896079533
Brand
ALEXANDER-FARABEUF RASPATORY
Company
SONTEC INSTRUMENTS, INC.
Model
430-396
Catalog number
430-396
Device description
ALEXANDER-FARABEUF RASPATORY
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896079533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896079533001928960795331928960795330192896079533

GMDN Terms#

Term, Definition table
TermDefinition
Bone raspatoryA hand-held, manually-operated, surgical instrument with a profiled, forward-scraping edge (sharp or blunt, sometimes double-sided) used to elevate and/or detach the periosteum (membrane of fibrous connective tissue tightly surrounding bone) from the underlying bone by a pushing action usually applied along the longitudinal axis of the bone. It is typically a one-piece instrument made of high-grade stainless steel; it is available in a wide variety of sizes and blade designs [e.g., slender or robust, curved, spoon-shaped, or flat (chisel-like)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.25Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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