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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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 non-powered device designed to hold or stabilize a video camera or endoscope (e.g., to a table or rail) 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
00810007560779AXSAA-04132020-07-09
00810007560007SPY-PHI SystemHH10012019-08-29
00810007560014SPY-PHI SystemHH10022019-08-29
00810007560038AXSAA-03032019-08-29
00810007560045AXSAA-04092019-08-29
00810007560052AXSAA-04832019-08-29
00810007560069AXSAA-05132019-08-29
00810007560076AXSAA-20102019-08-29
00810007560083AXSAA-20202019-08-29
00810007560090AXSAA-01202019-08-29
00810007560106AXSAA-20502019-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867514263Arthrex®ARTHREX, INC.FXR2026-01-26
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03700712422264Maquet EquipmentMAQUET SASFXR2023-07-03
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03700712422349Maquet EquipmentMAQUET SASFXR2023-07-03
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03700712422363Maquet EquipmentMAQUET SASFXR2023-07-03