FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380001459
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
65410-181
Catalog number
65410-181
Device description
Surgical Cautery - Fine Tip/High Temp
Published
2016-12-29
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

Product Codes#

Code, Name table
CodeName
HQPUnit, cautery, thermal, battery-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQPUnit, Cautery, Thermal, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121441000CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical Corporation2012-07-20HQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380001459PackageGS110In Commercial Distribution
00885380001454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088538000145950885380001459
00885380001454008853800014548853800014540885380001454

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, battery-poweredA battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886158106586BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106593BVIBeaver-Visitec International, Inc.HQP2025-09-10
00886158106609BVIBeaver-Visitec International, Inc.HQP2025-08-11
00886158034247BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034674BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158034681BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037569BVIBeaver-Visitec International, Inc.HQP2025-07-22
00886158037576BVIBeaver-Visitec International, Inc.HQP2025-07-22
10887482175160BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177119BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177133BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177157BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177171BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177201BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177225BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177249BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177263BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177287BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177409BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177423BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
10887482177508BovieASPEN SURGICAL PRODUCTS, INC.HQP2024-08-28
00887482177105BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177129BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177143BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177167BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177198BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177211BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177235BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177259BovieSYMMETRY SURGICAL INC.HQP2024-08-28
00887482177273BovieSYMMETRY SURGICAL INC.HQP2024-08-28