FDA.reportPublic FDA data

MTR

Primary DI
00859151005316
Brand
MTR
Company
MEDICAPTURE, INC.
Model
MTR245W
Published
2026-10-19
Public version status
New
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
FWHCamera, Cine, Surgical, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWHCamera, Cine, Surgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859151005316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859151005316008591510053168591510053160859151005316

GMDN Terms#

Term, Definition table
TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.

Regulatory Flags#

DUNS number
788868904
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00859151005323MSPMSP245W2026-10-19
00859151005330MSPMSP2452026-10-19
00859151005347MTRMTR245MTR2452026-10-19
00859151005361MTRMTR133W2026-10-19
00859151005378MTRMTR156W2026-10-19
00859151005385MTSMTS156W2026-10-19
00859151005293MSPMSP156MSP1562025-01-28
00859151005071MVRMVR460MVR4602025-01-28
00859151005095MTRMTR133MTR1332025-01-28
00859151005118MTRMTR156MTR1562025-01-28
00859151005064MVRMVR435MVR4352025-01-27
00859151005088MVRMVR450MVR4502025-01-27
00859151005309MVRMVR436MVR4362025-01-27
00859151005002MediCapUSB2002020-02-12
00859151005026MediCapUSB1702020-02-12
00859151005033MVRMVR4002020-02-12
00859151005019MediCapUSB3002020-02-12
00859151005101MVRMVR4092020-02-12
00859151005132MVRMVR4202020-02-12
00859151005170MVRMVR4082020-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859151005323MSPMEDICAPTURE, INC.FWH2026-10-19
00859151005330MSPMEDICAPTURE, INC.FWH2026-10-19
00859151005347MTRMEDICAPTURE, INC.FWH2026-10-19
00859151005361MTRMEDICAPTURE, INC.FWH2026-10-19
00859151005378MTRMEDICAPTURE, INC.FWH2026-10-19
00859151005385MTSMEDICAPTURE, INC.FWH2026-10-19
00859151005293MSPMEDICAPTURE, INC.FWH2025-01-28
00859151005057MTSMEDICAPTURE, INC.FWH2023-08-31
05055455519411SAIPH®MATORTHO LTDFWH2021-01-15