FDA.reportPublic FDA data

N/A

Primary DI
30885825013302
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
5DCD
Device description
Endopath Curved Dissector w/Unipolar Cautery
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUJELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885825013302PackageGS16In Commercial Distribution
00885825013301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088582501330230885825013302
00885825013301008858250133018858250133010885825013301

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessedA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, probe with controls) and requires a patient contact return electrode to complete the circuit. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327679571N/AD128622D1286222025-05-21
07613327666762N/A9898031450519898031450512025-02-24
07613327666786N/A9898031990719898031990712025-02-24
57613327666804N/A9898031975119898031975112025-02-24
07613327666939N/A9898032111719898032111712025-02-24
57613327664084Philips Healthcare014R014R2025-02-11
57613327664091Philips Healthcare85900P85900P2025-02-11
57613327664107Philips Healthcare85900PST85900PST2025-02-11
57613327664114Philips Healthcare88901889012025-02-11
57613327383923N/AN/A5921-024-145RP2019-08-04
57613327383930N/AN/A5921-030-135RP2019-08-04
57613327383947N/AN/A5921-030-236RP2019-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2025-05-21
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01
B504CBEN60000StrykerProvisionNUJ2024-05-22
B504CBEN70000StrykerProvisionNUJ2024-05-22
00850043377009AquamantysGREEN OR LLCNUJ2024-05-16
00850043377016AquamantysGREEN OR LLCNUJ2024-05-16
00850043377023Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377085AquamantysGREEN OR LLCNUJ2024-05-16
00850043377092Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377108AquamantysGREEN OR LLCNUJ2024-05-16
B504CB138505010ConMedProvisionNUJ2024-04-11
B390138505101Reprocessed MicroNeedle 3cmSURETEK MEDICALNUJ2024-02-20
B390E16511Reprocessed Straight Micro-Needle Electrode, 3cmSURETEK MEDICALNUJ2023-12-15
10080196385331MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277378384MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277379206MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277384408MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277384538MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
10888277386396MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277680415MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277680446MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277719412MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
20888277719436MedlineMEDLINE INDUSTRIES, INC.NUJ2023-10-09
B227RRFS26120NES Reprocessed RF Stylet (RFS)NORTH EAST SCIENTIFIC INCNUJ2023-07-12