FDA.report

OBWEGESER MANDIBLE RASPATORY

Primary DI
00192896038196
Brand
OBWEGESER MANDIBLE RASPATORY
Company
SONTEC INSTRUMENTS, INC.
Model
430-375
Catalog number
430-375
Device description
OBWEGESER MANDIBLE RASPATORY RIGHT ANGLED
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTRRASP

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896038196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896038196001928960381961928960381960192896038196

GMDN Terms

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

TypeValueUnit
Length7Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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
false
Sterilization required before use
true

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00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
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