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
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

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