FDA.reportPublic FDA data

SPY-PHI System

Primary DI
00810007560021
Brand
SPY-PHI System
Company
AXCESS SURGICAL INNOVATIONS, LLC
Model
HH1003
Device description
SPY-PHI Articulating Arm, Imaging Head Holder
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXRHolder, Camera, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXRHolder, Camera, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007560021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007560021008100075600218100075600210810007560021

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
968677414
Device count
1
Premarket exempt
true
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
00810007560519AXSAA-03012020-10-09
00810007560762AXSAA-01372020-10-09
00810007560786AXSAA-01062020-10-09
00810007560793AXSAA-01512020-10-09
00810007560809AXSAA-02122020-10-09
00810007560816AXSAA-03512020-10-09
00810007560823AXSAA-04532020-10-09
00810007560830AXSAA-2001-S2020-10-09
00810007560847AXSAA-2010-S2020-10-09
00810007560038AXSAA-03032019-08-29
00810007560052AXSAA-04832019-08-29
00810007560076AXSAA-20102019-08-29
00810007560083AXSAA-20202019-08-29
00810007560106AXSAA-20502019-08-29
00810007560212AXSAA-20412019-08-29
00810007560281AXSAA-20122019-08-29
00810007560304AXSAA-2010-DS2019-08-29
00810007560311AXSAA-20062019-08-29
00810007560328AXSAA-20012019-08-29
00810007560335AXSAA-20002019-08-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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