FDA.reportPublic FDA data

Stealth Surgical

Primary DI
00888515268784
Brand
Stealth Surgical
Company
BOSS INSTRUMENTS, LTD., INC.
Model
SS3302
Catalog number
SS3302
Device description
FELER-DUCKER RETRACTOR, 50 x 10mm, LEFT
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515268784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515268784008885152687848885152687840888515268784

GMDN Terms#

Term, Definition table
TermDefinition
Laminectomy retractor, self-retainingA self-locking, surgical instrument, used for separating the edges or drawing aside the margins of a surgical incision to permit excision of the lamina of the vertebral posterior arch; this can be necessary to expose a portion of the spinal cord for removal of a tumour, relief of pressure due to a fracture, or disc protrusion. The instrument may resemble a large pair of scissors with wide-angle blades which have fenestrated curved hooks, often terminating in sharp points, at the distal end to grasp the tissues. It is usually made of stainless steel and comes in a variety of designs. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(540)832-5580info@stealthsurgical.com
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags#

DUNS number
848522678
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888515202146BOSS Instruments77-322077-32202024-02-28
00888515328037BOSS InstrumentsVSX233VSX2332025-10-28
00888515328044BOSS InstrumentsVSG511VSG5112025-10-28
00888515272026Stealth SurgicalSS3923SS39232016-10-01
00888515272040Stealth SurgicalSS3925SS39252016-10-01
00888515272064Stealth SurgicalSS3927SS39272016-10-01
00888515217515BOSS Instruments80-624080-62402024-02-28
00888515217522BOSS Instruments80-624280-62422024-02-28
00888515217539BOSS Instruments80-624480-62442024-02-28
00888515217546BOSS Instruments80-624680-62462024-02-28
00888515217553BOSS Instruments80-624880-62482024-02-28
00888515217560BOSS Instruments80-625080-62502024-02-28
00888515217577BOSS Instruments80-625280-62522024-02-28
00888515217584BOSS Instruments80-625380-62532024-02-28
00888515217591BOSS Instruments80-625480-62542024-02-28
00888515217638BOSS Instruments80-626080-62602024-02-28
00888515217645BOSS Instruments80-626180-62612024-02-28
00888515217683BOSS Instruments80-627080-62702024-02-28
00888515217690BOSS Instruments80-627580-62752024-02-28
00888515217706BOSS Instruments80-627880-62782024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
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10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537779Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537816TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537854TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537861TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537878Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537885Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537908MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537915MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537960MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537977MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538004MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538042BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538066BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23