FDA.reportPublic FDA data

7D Surgical Cranial Sterilization Tray

Primary DI
00628341520461
Brand
7D Surgical Cranial Sterilization Tray
Company
7D Surgical ULC
Model
11-0010
Published
2019-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628341520461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341520461006283415204616283415204610628341520461

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system spatial register connectorA non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended to connect the system’s spatial register [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to a navigation fiducial marker, during computer assisted surgery (CAS); it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
204326292
Device count
1
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088866018CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866025CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866032CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866049CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866056CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866063CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866070CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866087CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866094CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866100CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866117CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866124CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866131CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866148CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866155CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866162CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866179CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866186CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866193CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866209CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866216CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866223CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866230CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866247CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866254CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866261CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866278CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866285CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866292CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866308CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29