FDA.reportPublic FDA data

N/A

Primary DI
03596010538222
Brand
N/A
Company
Smith & Nephew, Inc.
Model
7209134D
Catalog number
7209134D
Device description
REFURB PROBE CALIBRATED
Published
2016-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHACCESSORIES,ARTHROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010538222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010538222035960105382223596010538222

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556917435Real IntelligenceROB20040ROB200402024-04-10
00885556780886REAL INTELLIGENCEROB10013SROB10013S2022-01-13
00885556757321REAL INTELLIGENCEROB10013ROB100132020-07-02
03596010411020VERSABOND71271140712711402015-08-29
03596010494726VERSABOND71271340712713402015-08-29
03596010507372VERSABOND71271440712714402015-09-28
03596010033246NA1100281100282015-08-25
03596010038852NA1114301114302015-08-25
03596010038890NA1114341114342015-08-25
03596010041968BUCK1124281124282015-08-25
03596010384591MIXOR71270041712700412015-08-29
03596010384607MIXOR71270042712700422015-08-29
03596010384638MIXOR71270051712700512015-08-29
03596010384645MIXOR71270052712700522015-08-29
03596010437617RENOVATION71369045713690452015-08-30
03596010472175MIXOR71270060712700602015-08-29
03596010515018VORTEX71272001712720012015-08-29
03596010040077NA1118021118022015-08-25
00885556582213RALLY71271560712715602015-10-08
00885556582220RALLY71271570712715702015-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066524011751Trocar, sharp, Ø 2.9 mmXION GmbHNBH2026-10-29
04066524011768Obturator, blunt, conical, Ø 2.9 mmXION GmbHNBH2026-10-29
04066524011775Trocar sheath, Ø 3.8 mm, 1 stopcock, rotatable, 0°XION GmbHNBH2026-10-29
04066524011782Trocar sheath, Ø 3.8 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011799Trocar sheath, Ø 3.8 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011805Trocar sheath, Ø 3.8 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011812Trocar, sharp, Ø 4.2 mmXION GmbHNBH2026-10-29
04066524011829Obturator, conical, blunt, Ø 4.2 mmXION GmbHNBH2026-10-29
04066524011836Trocar sheath, Ø 6 mm, 1 stopcock, 0°XION GmbHNBH2026-10-29
04066524011843Trocar sheath, Ø 6 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011850Trocar sheath, Ø 6 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011867Trocar sheath, Ø 6 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011874Trocar sheath, Ø 6.5 mm, 1 stopcock, rotatable, 0°XION GmbHNBH2026-10-29
04066524011881Trocar sheath, Ø 6.5 mm, 1 stopcock, rotatable, 30°/70°XION GmbHNBH2026-10-29
04066524011898Trocar sheath, Ø 6.5 mm, 2 stopcocks, rotatable, 0°XION GmbHNBH2026-10-29
04066524011904Trocar sheath, Ø 6.5 mm, 2 stopcocks, rotatable, 30°/70°XION GmbHNBH2026-10-29
04250337112860Closing Cap for joimax® endoscopesJoimax GmbHNBH2026-10-29
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04250337121121HofHolderJoimax GmbHNBH2026-10-29
04250337121138HofHolderJoimax GmbHNBH2026-10-29
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04250337121152HofHolderJoimax GmbHNBH2026-10-29
04250337121169HofHolderJoimax GmbHNBH2026-10-29
04250337121985Reduction Tube for Laminoscope DeltaJoimax GmbHNBH2026-10-29
04250337122098Closing Cap for joimax® EndoscopesJoimax GmbHNBH2026-10-29
04250337122357Reduction Tube for Laminoscope DeltaJoimax GmbHNBH2026-10-29
00888867576070Arthrex®ARTHREX, INC.NBH2026-10-20
00888867576087Arthrex®ARTHREX, INC.NBH2026-10-20