FDA.reportPublic FDA data

Prophecy

Primary DI
00192629298859
Brand
Prophecy
Company
Microport Orthopedics Inc.
Model
PNV08019
Catalog number
PNV08019
Device description
PROPHECY® ALIGNMENT GUIDES
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629298859PrimaryGS10
M684PNV080191SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629298859001926292988591926292988590192629298859

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic/craniofacial surgical guideA custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00192629298675ProphecyPNV08001PNV080012020-09-25
00192629298682ProphecyPNV08002PNV080022020-09-25
00192629298699ProphecyPNV08003PNV080032020-09-25
00192629298705ProphecyPNV08004PNV080042020-09-25
00192629298712ProphecyPNV08005PNV080052020-09-25
00192629298729ProphecyPNV08006PNV080062020-09-25
00192629298736ProphecyPNV08007PNV080072020-09-25
00192629298743ProphecyPNV08008PNV080082020-09-25
00192629298750ProphecyPNV08009PNV080092020-09-25
00192629298767ProphecyPNV08010PNV080102020-09-25
00192629298774ProphecyPNV08011PNV080112020-09-25
00192629298781ProphecyPNV08012PNV080122020-09-25
00192629298798ProphecyPNV08013PNV080132020-09-25
00192629298804ProphecyPNV08014PNV080142020-09-25
00192629298811ProphecyPNV08015PNV080152020-09-25
00192629298828ProphecyPNV08016PNV080162020-09-25
00192629298835ProphecyPNV08017PNV080172020-09-25
00192629298842ProphecyPNV08018PNV080182020-09-25
00192629298866ProphecyPNV08020PNV080202020-09-25
00192629298873ProphecyPNV08021PNV080212020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298675ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.JWH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.MBH2020-09-25