FDA.reportPublic FDA data

Reprocessed Werewolf Irrigation Tube Set

Primary DI
B390722901351
Brand
Reprocessed Werewolf Irrigation Tube Set
Company
SURETEK MEDICAL
Model
72290135
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B390722901351PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
785616934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz197230FLA2026-04-30
B39019120501Reprocessed 4mm EndoScrub Sheath, 0 deg19-120502024-06-19
B390197230BVA1Reprocessed 4mm EndoScrub Sheath, 30 deg197230BVA2022-12-26
B3901912050T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12050T2023-12-27
B39019120271Reprocessed 2.7mm EndoScrub Sheath, 30 deg19-120272021-06-16
B3901912101Reprocessed 4mm EndoScrub Sheath, 30 deg1912102021-06-16
B3901912131Reprocessed 4mm EndoScrub Sheath, 45 deg1912132021-06-16
B3901912201Reprocessed 4mm EndoScrub Sheath, 70 deg1912202021-06-16
B3901912000T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing19-12000T2021-06-15
B3901912001Reprocessed 4mm EndoScrub Sheath, 0 deg1912002021-06-15
B390191200T1Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing191200T2021-06-15
B39019120101Reprocessed 4mm EndoScrub Sheath, 30 deg19-120102021-06-15
B39019120131Reprocessed 4mm EndoScrub Sheath, 45 deg, K Storz19-120132021-06-15
B39019120201Reprocessed 4mm EndoScrub Sheath, 70 deg19-120202021-06-15
B3901912000Reprocessed Endoscrub Sheath, 4mm, 0 deg19-120002021-06-14
B39016005391Reprocessed Shaver Blade Straight 3.5mm Double Serrated16005392025-12-09
B39016005741Reprocessed Shaver Blade Curved, 60 Deg, Double Serrated16005742025-12-09
B3901884002HRT1Reprocessed 4.0mm Serrated Blade, Rotatable, with Tubing18-84002HRT2025-12-09
B39062901120331Reprocessed 3mm Straight Shaver Blade6290-112-0332025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver Blade6290-112-040-122025-12-09

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