FDA.reportPublic FDA data

BihlerMed

Primary DI
10850009233032
Brand
BihlerMed
Company
BihlerMed, L.L.C.
Model
2658-01-0002
Device description
Surgical Light with Suction
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850009233039PackageGS15In Commercial Distribution
10865082000129PreviousGS10
10850009233032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085000923303920850009233039
1086508200012910865082000129
1085000923303210850009233032

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Contacts#

Phone, Email table
PhoneEmail
908-329-9123contact@bihlermed.com

Regulatory Flags#

DUNS number
828549936
Device count
1
Premarket exempt
true
Kit
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
10850009233049BihlerMed2762-01-00072026-07-24
10850009233056BihlerMed2762-01-00082026-07-24
10865082000105SurgiLight Adapter - Skytron2816-01-00042019-08-09
10865082000198SurgiLight Adapter - Table Mount2816-01-00032019-08-09
10850009233018SurgiLight Adapter - AIM-1002816-01-00092021-06-02
10865082000181View Medical SurgiLight2816-01-00012019-08-05
10865082000112Scintillant2658-01-00012016-08-19
10865082000129Scintillant2658-01-00022016-08-19
10865082000136Scintillant2658-01-00042016-08-19
10865082000167Safe-T-Surg2804-01-00012016-08-19
10865082000174SurgiLight Disposable Handle Assembly2816-01-00022019-08-09
20865082000164Safe-T-Surg2804-01-00012016-08-19
20865082000171SurgiLight Disposable Handle Assembly2816-01-00022019-08-09
10865082000143Scintillant2762-01-00032016-08-19
10865082000150Scintillant2762-01-00042016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850009233049BihlerMedBihlerMed, L.L.C.FTD2026-07-24
10850009233056BihlerMedBihlerMed, L.L.C.FTD2026-07-24
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
00190776403959MillenniumAvalign Technologies, Inc.JOL2026-07-22
00190776403966MillenniumAvalign Technologies, Inc.JOL2026-07-22
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
00846159040678SCANLAN® Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
10888277407954MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-07-17