FDA.reportPublic FDA data

IMPIX-MANTA

Primary DI
03613720236108
Brand
IMPIX-MANTA
Company
MEDICREA INTERNATIONAL
Model
A20350567
Device description
TRIAL KIT FOR IMPIX-MANTA LARGE (H: 5, 6, 7mm)
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720236108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720236108036137202361083613720236108

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
383228632
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
03613720286714IB3D™ PL Spinal SystemA240002302025-02-24
03613720286677IB3D™ PL Spinal SystemA240000002025-02-21
03613720286684IB3D™ PL Spinal SystemA240002002025-02-21
03613720286707IB3D™ PL Spinal SystemA240002202025-02-21
03613720286202IB3D™ PL Spinal SystemB241C080622092025-02-15
03613720286219IB3D™ PL Spinal SystemB241C090622092025-02-15
03613720286226IB3D™ PL Spinal SystemB241C100622092025-02-15
03613720286233IB3D™ PL Spinal SystemB241C110622092025-02-15
03613720286240IB3D™ PL Spinal SystemB241C120622092025-02-15
03613720286257IB3D™ PL Spinal SystemB241C130622092025-02-15
03613720286264IB3D™ PL Spinal SystemB241C140622092025-02-15
03613720286271IB3D™ PL Spinal SystemB241C150622092025-02-15
03613720286288IB3D™ PL Spinal SystemB241C160622092025-02-15
03613720286295IB3D™ PL Spinal SystemB241C170622092025-02-15
03613720286301IB3D™ PL Spinal SystemB241C091222092025-02-15
03613720286318IB3D™ PL Spinal SystemB241C101222092025-02-15
03613720286325IB3D™ PL Spinal SystemB241C111222092025-02-15
03613720286332IB3D™ PL Spinal SystemB241C121222092025-02-15
03613720286349IB3D™ PL Spinal SystemB241C131222092025-02-15
03613720286356IB3D™ PL Spinal SystemB241C141222092025-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131782LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19