SurgiLight Disposable Handle Assembly

GUDID 20865082000171

The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.

BihlerMed, L.L.C.

Medical equipment handle cover, single-use
Primary Device ID20865082000171
NIH Device Record Key5b33c8cc-a56c-42ab-a512-b14eab8c4b6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiLight Disposable Handle Assembly
Version Model Number2816-01-0002
Company DUNS828549936
Company NameBihlerMed, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com
Phone908-329-9123
Emailcontact@bihlermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110865082000174 [Primary]
GS120865082000171 [Package]
Contains: 10865082000174
Package: Box [6 Units]
In Commercial Distribution

FDA Product Code

FTALight, Surgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-11-06
Device Publish Date2019-08-09

Devices Manufactured by BihlerMed, L.L.C.

10865082000105 - SurgiLight Adapter - Skytron2023-11-06 An adapter used specifically to secure the View Medical SurgiLight to the light handle of operating room compatible overhead Sky
20865082000164 - Safe-T-Surg2023-11-06 Safe-T-Surg Retractor
20865082000171 - SurgiLight Disposable Handle Assembly2023-11-06The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.
20865082000171 - SurgiLight Disposable Handle Assembly2023-11-06 The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the
10865082000198 - SurgiLight Adapter - Table Mount2023-11-06 An adapter used specifically to secure the View Medical SurgiLight to a table side rail accessory.

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