FDA.reportPublic FDA data

ThermaClear

Primary DI
07613327626469
Brand
ThermaClear
Company
STRYKER CORPORATION
Model
P01790
Catalog number
P01790
Published
2025-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVTTubing and tubing/filter fits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVTTubing And Tubing/Filter FitsObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327626469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327626469076133276264697613327626469

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
187502109
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30
07613327507997Stroke Fast PackSFP913100SFP9131002020-06-30
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055270979636RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979667RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986504RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979643RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979674RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986511RocketROCKET MEDICAL PLCNVT2023-10-24
05708265011179LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011841LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011186LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011858LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
04048438003497n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438003619n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004401n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004692n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438001080n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000762n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000823n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438006306n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
05708265010585LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
05708265010592LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
00815849020191Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020207Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020214Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022461Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020764Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020771Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020788Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022478Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09