FDA.reportPublic FDA data

7D Surgical FLASH Frame

Primary DI
00628341520621
Brand
7D Surgical FLASH Frame
Company
7D Surgical ULC
Model
11-0048
Published
2022-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628341520621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341520621006283415206216283415206210628341520621

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204326292
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006283415208297D Surgical FLASH EVD Procedural Kit11-00722026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit11-00732026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit11-00742026-04-08
00628341521352FLASH EVD System10-00022026-04-08
006283415213837D Surgical Universal Array (5)11-01412025-07-28
006283415213907D Surgical Universal Array (6)11-01422025-07-28
006283415208507D Surgical Reference Clamp (Gator)11-00962023-01-12
006283415210247D Surgical Flex Rod Connector (4.5 mm - 100 mm)11-01132023-08-18
006283415208747D Surgical Spine Reference Clamp (Multi-Level)11-00982023-07-31
006283415207997D Surgical Pedicle Probe (Slim)11-00922022-09-21
006283415208057D Surgical Universal Array 311-00932022-09-21
006283415208127D Surgical Universal Array 411-00942022-09-21
006283415205777D Surgical Universal Clamp (Stryker Adapter)11-006711-00672020-11-18
006283415206907D Surgical Universal Clamp (SeaSpine Adapter)11-00792022-01-11
006283415207067D Surgical Inserter, Lumbar11-00852021-12-31
006283415207137D Surgical Navigation Guide, T-Handle11-00862021-12-31
006283415207207D Surgical Facet Array Adaptor11-00872021-12-31
006283415205607D Surgical Pedicle Probe (Sharp)11-00552021-02-12
006283415205227D Surgical Spine Reference Clamp (Radiolucent)11-00572021-01-06
006283415204787D Surgical Flex Array11-00532020-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27
00889024674790ROSA PIN STABILIZER 60MMOrthosoft IncOLO2025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 3Orthosoft IncOLO2025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 6Orthosoft IncOLO2025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MMOrthosoft IncOLO2025-12-11
00889024687455ROSA® KneeOrthosoft IncOLO2025-11-21
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06