FDA.reportPublic FDA data

Hensler Surgical Disposable Non-Stick Bipolar

Primary DI
00853755004225
Brand
Hensler Surgical Disposable Non-Stick Bipolar
Company
Hensler Surgical
Model
HSP-003
Device description
"Bayoneted bipolar forcep, Non-stick, single-use, yellow, 8"" length, 0.5 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
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
10853755004222PackageGS15In Commercial Distribution
00853755004225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085375500422210853755004222
00853755004225008537550042258537550042250853755004225

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
Length8Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
023924230
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
10853755004239Hensler Surgical Disposable Non-Stick BipolarHSP-0042025-04-03
10853755004246Hensler Surgical Disposable Non-Stick BipolarHSP-0052025-04-03
10853755004253Hensler Surgical Disposable Non-Stick BipolarHSP-0062025-04-03

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