FDA.report

Sonoma Orthopedic Products, Inc

Primary DI
00816988012115
Brand
Sonoma Orthopedic Products, Inc
Company
SONOMA ORTHOPEDIC PRODUCTS, INC.
Model
MINI-CRX®3.2x90mm
Catalog number
FST-32090
Published
2015-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816988012115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816988012115008169880121158169880121150816988012115

GMDN Terms

TermDefinition
Clavicle fixation pinA small-diameter rod used for the fixation of a bone fracture or bone grafts, an osteotomy, or an arthrodesis, in the presence of additional immobilization, typically to treat midshaft fractures, nonunions, and malunions of the clavicle bone. The rod may be smooth or partially-threaded and may be fitted with a securing nut and is capable of being fitted into the intramedullary canal of the clavicle through a small incision. It is typically made of surgical stainless steel. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
884789251
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00816988010197Sonoma Orthopedic Products, Inc2.7mm Bone Screw Caddy/ CoverIN01182015-09-17
00816988010739Sonoma Orthopedic Products, IncSONOMA WRX Inner Sterilization CaseIN01032015-09-17
00816988010746Sonoma Orthopedic Products, IncScrew Caddy With Peg CaddyIN01042015-09-17
00816988012030Sonoma Orthopedic Products, IncInstrument CaseIN68002015-08-19
00816988012047Sonoma Orthopedic Products, IncInstrument Case Inner TrayIN68012015-08-19
00816988012054Sonoma Orthopedic Products, IncInstrument Case LidIN68022015-08-19
00816988012368Sonoma Orthopedic Products, Inc.Fib First Gen Bottom Insert TrayIN68032017-07-07
00816988012467Sonoma Orthopedic Products, Inc.Fibulock Instrument Gase Gen2IN68052016-02-04
00816988012474Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Base Gen2IN6805-012016-02-04
00816988012481Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Lid Gen2IN6805-022016-02-04
00816988012498Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Insert Tray Gen2IN6805-032016-02-04
00816988012504Sonoma Orthopedic Products, Inc.Fibulock Instrument Case Screw Caddy and Lid Gen2IN6805-042016-02-04
00816988013068Sonoma Orthopedic Products, Inc.Jones Bolt Instrument Tray BaseIN7800-012017-04-04
00816988013075Sonoma Orthopedic Products, Inc.Jones Bolt Instrument Tray LidIN7800-022017-04-04
00816988013174Sonoma Orthopedic Products, Inc.WRx Tray with Irremovable Innermost TrayIN01492017-09-20
00816988011446Sonoma Orthopedic Products, IncCRx DISPOSABLE INTRUMENTS PACKAGEST0101_A2015-09-08
00816988010593Sonoma Orthopedic Products, IncWRx OutriggerIN01502015-09-17
00816988010609Sonoma Orthopedic Products, Inc5mm Hub Attachment Tube "Outrigger"IN01512015-09-17
00816988010616Sonoma Orthopedic Products, Inc5mm Hub Attachment Screw "Outrigger"IN01522015-09-17
00816988010630Sonoma Orthopedic Products, Inc6mm Hub Attachment Screw "Outrigger"IN01622015-09-17

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