FDA.reportPublic FDA data

Oakworks Medical

Primary DI
00817463027136
Brand
Oakworks Medical
Company
OAKWORKS, INC.
Model
Powerline Table Extender
Device description
For use with Oakworks Powerline tables to extend table length: intended for use by healthcare professional
Published
2023-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817463027136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817463027136008174630271368174630271360817463027136

GMDN Terms#

Term, Definition table
TermDefinition
Operating/examination/treatment table headrest, reusableA device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. It is available in various shapes and sizes and might include mechanisms to enable adjustments in relation to the table top. It does not include components intended for immobilization of the head (i.e., not a positioner). This is a reusable device after appropriate cleaning.

Regulatory Flags#

DUNS number
130256837
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817463026719Oakworks MedicalPT100 Table2023-08-08
00817463027242Oakworks MedicalProcedure Chair Prone Face Rest System2023-12-13
00817463026436Oakworks MedicalUrology Table Drape2023-12-06
00817463027129Oakworks MedicalDetachable Arm Board2023-12-06
00817463027143Oakworks MedicalPowerline Table Extender2023-12-06
00817463027174Oakworks MedicalPatient Strap - Ultrasound EA2023-12-06
00817463026870Oakworks MedicalPT300 Table2023-10-03
00817463026887Oakworks MedicalPT300 Table2023-10-03
00817463025378Oakworks MedicalUltrasound EA General 2 Section Table or Echocardi2023-10-02
00817463025385Oakworks MedicalUltrasound EA General 2 Section Table or Multi-Spe2023-10-02
00817463025408Oakworks MedicalUltrasound EA General 2 Section Table2023-10-02
00817463025460Oakworks MedicalUltrasound EA General 3 Section Table2023-10-02
00817463025477Oakworks MedicalUltrasound EA General 3 Section Table or Echocard2023-10-02
00817463026894Oakworks MedicalPT300 Table2023-10-02
00817463026931Oakworks MedicalPT400 Table2023-10-02
00817463026948Oakworks MedicalPT400 Table2023-10-02
00817463026955Oakworks MedicalPT400 Table2023-10-02
00817463026979Oakworks MedicalPT400M Table2023-10-02
00817463025484Oakworks MedicalUltrasound EA General 3 Section Table or Multi-Spe2023-09-29
00817463025491Oakworks MedicalUltrasound EA General 3 Section Table or Women's (2023-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975582544010CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544027CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544034CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544041CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
06975582544058CoinfycareHuangshan Jinfu Medical Equipment Co.,Ltd.LGX2026-08-17
00848871001500EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001517EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001524EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
04260647941524ak 5010 MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942040Additive Back support MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942057Additive Back support (viscoel.) MBSAKRUS GmbH & Co. KGLGX2025-11-28
04260647942064Adapter footrest MBSAKRUS GmbH & Co. KGLGX2025-11-28
00667259004007Laguna Edge (2M)Silhouet-Tone CorporationLGX2025-11-12
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00728564157014Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158004Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564158011Flex Plus Access Exam TableThe Brewer Company, LLCLGX2025-11-10
00728564160007Access HLT Plus Exam TableThe Brewer Company, LLCLGX2025-11-10