FDA.reportPublic FDA data

Hensler Surgical Irrigating Non-stick bipolar

Primary DI
10853755004383
Brand
Hensler Surgical Irrigating Non-stick bipolar
Company
Hensler Surgical
Model
HSP-IR915
Device description
Bayoneted irrigating bipolar forcep, Non-stick, single-use, yellow, 9" length, 1.5 mm tip, STERILE
Published
2025-04-03
Public version status
New
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
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
10853755004383PackageGS15In Commercial Distribution
00853755004386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085375500438310853755004383
00853755004386008537550043868537550043860853755004386

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length9Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
910-399-7380tj@henslersurgical.com

Regulatory Flags#

DUNS number
023924230
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
true
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
00853755004232Hensler Surgical Disposable Non-Stick BipolarHSP-0042025-04-03
00853755004249Hensler Surgical Disposable Non-Stick BipolarHSP-0052025-04-03
00853755004256Hensler Surgical Disposable Non-Stick BipolarHSP-0062025-04-03
00853755004263Hensler Surgical Disposable Non-Stick BipolarHSP-0072025-04-03
00853755004270Hensler Surgical Disposable Non-Stick BipolarHSP-0082025-04-03
00853755004287Hensler Surgical Disposable Non-Stick BipolarHSP-0092025-04-03
00853755004294Hensler Surgical Disposable Non-Stick BipolarHSP-0102025-04-03
00853755004300Hensler Surgical Disposable Non-Stick BipolarHSP-0112025-04-03
00853755004317Hensler Surgical Disposable Non-Stick BipolarHSP-0122025-04-03
00853755004324Hensler Surgical Disposable Non-Stick BipolarHSP-0132025-04-03
00853755004331Hensler Surgical Disposable Non-Stick BipolarHSP-0142025-04-03
00853755004348Hensler Surgical Disposable Non-Stick BipolarHSP-0152025-04-03
00853755004355Hensler Surgical Disposable Non-Stick BipolarHSP-0162025-04-03
00853755004379Hensler Surgical Irrigating Non-stick bipolarHSP-IR8152025-04-03
00853755004386Hensler Surgical Irrigating Non-stick bipolarHSP-IR9152025-04-03
00853755004393Hensler Surgical Disposable Non-Stick BipolarHSP-0192025-04-03
00853755004409Hensler Surgical Disposable Non-Stick BipolarHSP-0202025-04-03
00853755004225Hensler Surgical Disposable Non-Stick BipolarHSP-0032025-04-03
10853755004239Hensler Surgical Disposable Non-Stick BipolarHSP-0042025-04-03
10853755004246Hensler Surgical Disposable Non-Stick BipolarHSP-0052025-04-03

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