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
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

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