FDA.reportPublic FDA data

BihlerMed

Primary DI
10850009233056
Brand
BihlerMed
Company
BihlerMed, L.L.C.
Model
2762-01-0008
Device description
BihlerMed Dual Bent Tip Surgical Light
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133425000SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLC2013-12-05FTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850009233056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085000923305610850009233056

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850009233049BihlerMed2762-01-00072026-07-24
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
10850009233032BihlerMed2658-01-00022026-01-12
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
10194665008857A-decA-DEC, INC.FTD2026-05-07
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
08800053093767S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093774S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093781S300 Series DENTIS CO. ,LTDFTD2025-02-19
08800053093798S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093804S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093828S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093835S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093842S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093859S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093866S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093873S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093880S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093897S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093903S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093910S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093927S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19