FDA.reportPublic FDA data

Panther OIS

Primary DI
00859032007224
Brand
Panther OIS
Company
Prowess, Inc.
Model
3.1
Device description
Panther OIS 3.1
Published
2024-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211760000Panther OISProwess, Inc.2021-09-28IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859032007224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859032007224008590320072248590320072240859032007224

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002162728
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859032007132Panther TPS5.72021-11-01
00859032007392Panther TPS6.42026-10-14
00859032007385Panther OIS3.52026-09-22
00859032007361Panther OIS3.42026-06-09
00859032007378Panther TPS6.32026-06-09
00859032007316Panther TPS6.12026-06-01
00859032007323Panther TPS6.22026-06-01
00859032007330Panther OIS3.32026-06-01
00859032007347Panther TPS6.212026-06-01
00859032007354Panther OIS3.312026-06-01
00859032007088Panther TPSv5.612021-11-01
00859032007095Panther OIS R&Vv2.312021-11-01
00859032007033Panther OIS R&V2.22024-12-19
00859032007170Panther TPS5.72024-12-19
00859032007194Panther TPS5.72024-12-19
00859032007200Panther TPS5.82024-12-19
00859032007231Panther TPS5.812024-12-19
00859032007248Panther OIS3.112024-12-19
00859032007255Panther TPS5.92024-12-19
00859032007262Panther OIS3.122024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355027046KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00840510401696KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00841439120590TotalRTQfixIYE2026-11-04
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21