FDA.reportPublic FDA data

Sonoma Orthopedic Products, Inc

Primary DI
00816988011835
Brand
Sonoma Orthopedic Products, Inc
Company
SONOMA ORTHOPEDIC PRODUCTS, INC.
Model
Compression Driver
Catalog number
IN6040
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
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816988011835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816988011835008169880118358169880118350816988011835

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-fragment manipulator, reusableA hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
884789251
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

Other Devices From This Company#

Primary DI, Brand, Model table
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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