FDA.reportPublic FDA data

Omni Hysteroscopy Light Set

Primary DI
15420045510340
Brand
Omni Hysteroscopy Light Set
Company
Hologic, Inc.
Model
60-250-2
Published
2018-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182006000Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.2018-12-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045510340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551034015420045510340

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15420045518452DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185882026-10-19
15420045518933DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185892026-10-19
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
15420045515796EnvisionEnvision System Software LicenseCMP-019182026-10-09
15420045515802EnvisionEnvision Tomosynthesis LicenseCMP-029192026-10-09
15420045515864EnvisionEnvision Tomo Synthesized 2D LicenseCMP-019212026-10-09
15420045515871EnvisionEnvision 3DQorum LicenseCMP-019222026-10-09
15420045515895EnvisionEnvision SmartCurve Paddle LicenseCMP-019242026-10-09
15420045517462EnvisionENV-SYS-STDENV-SYS-STD2026-10-09
15420045517479EnvisionENV-SYS-STD-NSENV-SYS-STD-NS2026-10-09
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551279618n.a.Karl Storz GmbH & Co. KGHIH2026-11-02
04048551431603n.a.Karl Storz GmbH & Co. KGHIH2026-11-02
00888937027495Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00888937027501Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00888937027556Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00888937027563Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00850006759507Aveta Cervical SealMEDITRINA, INC.HIH2026-10-05
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00850033976373HERizon Vista ViewPoint Endoscopic Video Image ProcessorMinerva Surgical, Inc.HIH2026-04-01
00850033976380HERizon Vista Single Use Hysteroscope, DiagnosticMinerva Surgical, Inc.HIH2026-04-01
00850033976397HERizon Vista Single Use Hysteroscope, Model 2Minerva Surgical, Inc.HIH2026-04-01
00850033976403HERizon Vista Single Use Hysteroscope, PlusMinerva Surgical, Inc.HIH2026-04-01
00850033976410HERizon Vista Single Use Hysteroscope, ProMinerva Surgical, Inc.HIH2026-04-01
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00850033976267HERizon Disposable Electronic HysteroscopeMinerva Surgical, Inc.HIH2024-10-07
00850033976250HERizon Medical Endoscope Image ProcessorMinerva Surgical, Inc.HIH2024-10-07
00850033976236INFINITY Fluid Management AccessoryMinerva Surgical, Inc.HIH2024-08-12
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27