FDA.reportPublic FDA data

7D Surgical Biopsy Arm

Primary DI
00628341520140
Brand
7D Surgical Biopsy Arm
Company
7D Surgical ULC
Model
11-0025
Published
2020-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00628341520140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628341520140006283415201406283415201400628341520140

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical tracking system spatial marker connectorA component of a surgical navigation and/or tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system) intended to connect the system’s spatial marker [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 another marker; 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
204326292
Device count
1
DM exempt
false
Premarket exempt
false
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
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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Primary DI, Brand, Company table
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07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
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