FDA.reportPublic FDA data

HMDmd Wearable Surgical Monitor

Primary DI
00860014850509
Brand
HMDmd Wearable Surgical Monitor
Company
HMDMD INC.
Model
CR3
Device description
The CR3 Wearable Surgical Monitor is a wearable monitor worn by trained healthcare professionals duringvideoscopic procedures and as adjunct to conventional video monitors
Published
2025-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPTMicroscope, Surgical
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014850509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014850509008600148505098600148505090860014850509

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Contacts#

Phone, Email table
PhoneEmail
617-791-1120james.lockwood@hmdmd.com

Regulatory Flags#

DUNS number
138342971
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
07630003501421M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501629M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501636M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501643M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
00840183528461BR Surgical, LLCBR Surgical, LLCEPT2024-11-07
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
00850047802002Prescott’s Wall Mount Surgical Microscope PlatformPrescott's Inc.EPT2024-02-22
00850047802019 OSM200 StandPrescott's Inc.EPT2024-02-22
14714127861392AESCULAPAesculap AGKQM2023-11-05
00887761967267Sterilizable HandlesBaxter Medical Systems GmbH + Co. KGKQM2023-07-11
30845854050730CONMEDConmed CorporationKQM2023-06-16
10618125131041DEXcam3™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
10618125155870DEXcam4™ Intra-oral Camera SheathsTIDI PRODUCTS, LLCKQM2023-04-13
00860009669147SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669154SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669161SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669178SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13