FDA.reportPublic FDA data

7D Surgical Modular 2.2mm Drill Bit

Primary DI
00628341520249
Brand
7D Surgical Modular 2.2mm Drill Bit
Company
7D Surgical ULC
Model
11-0037
Published
2021-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00628341520249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341520249006283415202496283415202490628341520249

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
204326292
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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

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