FDA.reportPublic FDA data

PhotonGuide

Primary DI
00816728020080
Brand
PhotonGuide
Company
STRYKER CORPORATION
Model
Wide / Flat
Catalog number
104015
Device description
Illuminator, Wide/Flat
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSZLight, Surgical, Carrier

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSZLight, Surgical, CarrierGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816728020080PrimaryGS10
00816728020646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728020080008167280200808167280200800816728020080
00816728020646008167280206468167280206460816728020646

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument fibreoptic lightA sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667117768customerservice@invuity.com
+0118667117768customerservice@invuity.com
+0118002533210inst.stryker.cs@stryker.com
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M678TLCSLS0TracLuxSUNOPTIC TECHNOLOGIES LLCFSZ2023-05-29
M678TLC0TRACLUXSUNOPTIC TECHNOLOGIES LLCFSZ2021-11-05
00816728020646PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020653PhotonGuideINVUITY, INC.FSZ2019-06-03
00816728021650PhotonGuideSTRYKER CORPORATIONFSZ2019-06-03
00816728020479PhotonGuide AdaptINVUITY, INC.FSZ2019-06-03
00816728021315PhotonGuide AdaptSTRYKER CORPORATIONFSZ2019-04-19
00643169857834N/AMEDTRONIC SOFAMOR DANEK, INC.FSZ2018-12-20
00816728020066PhotonGuideINVUITY, INC.FSZ2016-09-22
00816728020073PhotonGuideSTRYKER CORPORATIONFSZ2016-09-22
00816728020097PhotonGuideINVUITY, INC.FSZ2016-09-22