FDA.reportPublic FDA data

XHL XENON HALOGEN SPARE BULB

Primary DI
00192896092549
Brand
XHL XENON HALOGEN SPARE BULB
Company
SONTEC INSTRUMENTS, INC.
Model
X-004.88.11
Catalog number
X-004.88.11
Device description
XHL XENON HALOGEN SPARE BULB #111
Published
2019-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope
FSPLoupe, Diagnostic/Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896092549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896092549001928960925491928960925490192896092549

GMDN Terms#

Term, Definition table
TermDefinition
Intubation light sourceA device designed as a handle containing a light source used to provide cold light illumination for a patient's airways during access, intubation, and airway management. It is a pistol-grip-like device that contains the batteries that provide energy for the airway-illuminating lighting for the attached fibreoptic stylet and an illumination source (e.g., a halogen light bulb). This device is used together with other devices, e.g., stylets, oxygen (O2) connectors, a camera adaptor, typically to manage and document difficult airway intubations. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11
00192896038134SONTEC-MICHELE TREPHINE419-394419-3942018-09-11
00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
00192896038158SONTEC-MICHELE TREPHINE419-396419-3962018-09-11
00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10884389104521MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21
10615375009601Orascoptic - OmniOptic HDL 3.5METREX RESEARCH, LLCFSP2022-12-08
10615375009618Orascoptic - OmniOptic HDL 4.5METREX RESEARCH, LLCFSP2022-12-08
00615375001158Orascoptic - HDL 2.5 MicroMETREX RESEARCH, LLCFSP2022-12-08
00615375001172Orascoptic - HDL 3.0METREX RESEARCH, LLCFSP2022-12-08
00615375001271Orascoptic - EyeZoomMETREX RESEARCH, LLCFSP2022-12-08
00615375001295Orascoptic - RDH EliteMETREX RESEARCH, LLCFSP2022-12-08
00615375008614Orascoptic - HDL 3.5METREX RESEARCH, LLCFSP2022-12-08
00615375008638Orascoptic - HDL 4.5METREX RESEARCH, LLCFSP2022-12-08
00615375008652Orascoptic - HDL 5.5METREX RESEARCH, LLCFSP2022-12-08
00615375008676Orascoptic - EyeZoom MiniMETREX RESEARCH, LLCFSP2022-12-08
00615375009550Orascoptic - Safety FrameMETREX RESEARCH, LLCFSP2022-12-08
00615375009574Orascoptic - OmniOpticMETREX RESEARCH, LLCFSP2022-12-08
00615375009833Orascoptic - HDL 2.5 Micro RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009857Orascoptic - HDL 3.0 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009956Orascoptic - EyeZoom RxMETREX RESEARCH, LLCFSP2022-12-08
00615375009970Orascoptic - RDH Elite RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010006Orascoptic - HDL 3.5 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010020Orascoptic - HDL 4.5 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010044Orascoptic - HDL 5.5 RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010068Orascoptic - EyeZoom Mini RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010099Orascoptic - OmniOptic RxMETREX RESEARCH, LLCFSP2022-12-08
00615375010112Orascoptic - Safety Frame RxMETREX RESEARCH, LLCFSP2022-12-08