FDA.reportPublic FDA data

Playbook

Primary DI
00840194493765
Brand
Playbook
Company
ORTHOPEDIATRICS CORP.
Model
NS-4200-0001
Catalog number
NS-4200-0001
Device description
Assembled Playbook Surgical Unit
Published
2024-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194493765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194493765008401944937658401944937650840194493765

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840194417341PNP Femur01-1501-052501-1501-05252026-10-01
00841132136010Locking Cannulated Blade Plate01-1200-111101-1200-11112017-02-15
00841132177570OrthoPediatrics QuickPack Bone Void FillerOPQS1005OPQS10052020-02-11
00841132177587OrthoPediatrics QuickPack Bone Void FillerOPQS1008OPQS10082020-02-11
00841132177594OrthoPediatrics QuickPack Bone Void FillerOPQS1016OPQS10162020-02-11
00841132177600OrthoPediatrics QuickPack Bone Void FillerOPQS0004OPQS00042020-02-11
00840536824288PediHipNS-5001-1711NS-5001-17112026-10-07
00840536824295PediHipNS-5001-1712NS-5001-17122026-10-07
00840536824301PediHipNS-5001-1713NS-5001-17132026-10-07
00840536824318PediHipNS-5001-1714NS-5001-17142026-10-07
00840536824325PediHipNS-5001-1715NS-5001-17152026-10-07
00840536824332PediHipNS-5001-1716NS-5001-17162026-10-07
00840536824349PediHipNS-5001-1721NS-5001-17212026-10-07
00840536824356PediHipNS-5001-1722NS-5001-17222026-10-07
00840536824363PediHipNS-5001-1723NS-5001-17232026-10-07
00840536824370PediHipNS-5001-1724NS-5001-17242026-10-07
00840536824387PediHipNS-5001-1725NS-5001-17252026-10-07
00840536824394PediHipNS-5001-1726NS-5001-17262026-10-07
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521856271Touch SurgeryCovidien LPOUG2026-10-16
06945087500262MediWorksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
06945087500439EssilorSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.OUG2026-10-09
00850015699191Cloud Data Management PlatformCanary Medical USA LLCOUG2026-10-08
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24