FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463022421
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Arm Hammock
Device description
Designed for use only on Oakworks CFPM IH Tables, used to support arms while in the prone position during procedures. It is intended to be used by a healthcare professional.
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IXQTable, Radiographic, Stationary Top
IXRTable, Radiographic, Tilting
IZZTable, Radiographic, Non-Tilting, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXQTable, Radiographic, Stationary TopRadiology2
IXRTable, Radiographic, TiltingRadiology2
IZZTable, Radiographic, Non-Tilting, PoweredRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463022421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463022421008174630224218174630224210817463022421

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130256837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817463026412Oakworks Medical Adjustable T-Rail Clamp Accessory-12in2023-12-06
00817463026870Oakworks Medical PT300 Table2023-10-03
00817463026887Oakworks Medical PT300 Table2023-10-03
00817463025361Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
00817463025378Oakworks Medical Ultrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks Medical Ultrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks Medical Ultrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks Medical Ultrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks Medical Ultrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks Medical PT300 Table2023-10-02
00817463026931Oakworks Medical PT400 Table2023-10-02
00817463026948Oakworks Medical PT400 Table2023-10-02
00817463026955Oakworks Medical PT400 Table2023-10-02
00817463026979Oakworks Medical PT400M Table2023-10-02
00817463025484Oakworks Medical Ultrasound EA General 3 Section Table or Multi-Spe2023-09-29
00817463025491Oakworks Medical Ultrasound EA General 3 Section Table or Women's (2023-09-29
00817463025507Oakworks Medical Ultrasound EA General 3 Section Table2023-09-28
00817463025569Oakworks Medical Ultrasound EA Vascular Table2023-09-28
00817463025576Oakworks Medical EA Vascular Table with Fowler (V2 Model)2023-09-28
00817463025606Oakworks Medical Ultrasound EA Vascular Table2023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439115213Alta Indexing BarMEDTEC, INC.IXQ2026-05-06
00841439115152Upright Arm PositionerMEDTEC, INC.IXQ2026-01-08
00841439115145PronumbraMEDTEC, INC.IXQ2025-10-23
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
00841439114650PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114674PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114681PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114698PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114704PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114711PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114728PronumbraMEDTEC, INC.IXQ2025-09-12
00841439114995PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115008PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115084ONEFitMEDTEC, INC.IXQ2025-09-12
00841439115121PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115138PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114732PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114749PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114770PronumbraMEDTEC, INC.IXQ2025-09-12
10841439114787PronumbraMEDTEC, INC.IXQ2025-09-12
00841439115015Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
00841439115022Adjustable BackrestMEDTEC, INC.IXQ2025-04-23
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
08800011101145DRGEMDRGEM CorporationIZZ2025-02-11
00841439115039Posi Indexing BarMEDTEC, INC.IXQ2025-01-02
05999116100023PHOENIX 1CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIZZ2024-10-30
00841439114766Universal Couchtop™MEDTEC, INC.IXQ2024-10-18
00841439114759Rectangular ExtensionMEDTEC, INC.IXQ2024-10-01
B237OGSAPH100Diacor CT OverlayDiacor, Inc.IXQ2024-07-11