FDA.reportPublic FDA data

ThermaClear

Primary DI
07613327626391
Brand
ThermaClear
Company
STRYKER CORPORATION
Model
502500001
Catalog number
502500001
Published
2025-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIGInsufflator, hysteroscopic
LGZWarmer, thermal, infusion fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210628000X-FLO Fluid Management SystemThermedx, LLC2021-11-04HIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327626391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327626391076133276263917613327626391

GMDN Terms#

Term, Definition table
TermDefinition
Hysteroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15
07613327504019NA5407-150-0005407-150-0002021-07-08
07613327504057NA5407-350-0005407-350-0002021-07-08
07613154495771NA62930000006293-000-0002015-09-24
07613154495801NA62970000006297-000-0002015-09-24
07613154495818NA62980000006298-000-0002015-09-24
07613154501410Electric System 6 Stryker Precision62990000006299-000-0002018-09-23
00850002250411ClariFixCFX-2002CFX-20022020-09-01
04546540517593ESSx52906012005290-601-2002016-09-24
07613327665109Sonopet iQ+55002600005500-260-0002026-10-14
07613327685114Sonopet iQ57000500005700-050-0002026-10-14
07613327665031Sonopet iQ+550026B0105500-26B-0102026-10-12
07613327665048Sonopet iQ+550026B0205500-26B-0202026-10-12
07613327665055Sonopet iQ+550026B1145500-26B-1142026-10-12
07613327665062Sonopet iQ+550026B3125500-26B-3122026-10-12
07613327687149Sonopet iQ+550026B3285500-26B-3282026-10-12
07613327662030ALPHAVENT3911-856-5473911-856-5472025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006759507Aveta Cervical SealMEDITRINA, INC.HIG2026-10-05
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B286SWC243074MBST1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-30
B286DWC183074TLG4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-09-18
B286DWC182464TG4B220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETM.A.C. MEDICAL INC.LGZ2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464T4B1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242464TMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474EGMB220C1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR21Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286DWC242474TG4BR2SB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-18
B286243074TGMB1Dual Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-17
B286SWC242464GMB1single Chamber Warming CabinetM.A.C. MEDICAL INC.LGZ2026-08-14
00841027105749Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-24
00841027105725Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-07-12