FDA.reportPublic FDA data

OWL

Primary DI
00825114000490
Brand
OWL
Company
Diros Technology Inc
Model
D7506NC
Catalog number
D7506NC
Device description
OWL GD-PAD PATIENT RETURN ELECTRODE, NON-CORDED
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00825114008434PackageGS1250In Commercial Distribution
825114008434PackageGS1250In Commercial Distribution
00825114000490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825114008434008251140084348251140084340825114008434
00825114000490008251140004908251140004900825114000490

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-use, non-sterileA non-sterile dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool Dry Place, Away from Extreme Temperature, Humidity and Direct Sunlight
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9054153440RBAKER@DIROSTECH.COM

Regulatory Flags#

DUNS number
202738675
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
00825114014862OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114014879OWLDHC-022/60/10DHC-022/60/102025-07-16
00825114000032OWLURF-2AP553-1002023-06-19
00825114001664OWLD463-005D463-0052016-09-01
00825114001732OWLD467-005-TCD467-005-TC2016-09-23
00825114001862OWL467-022/54/4467-022/54/42016-09-01
00825114001879OWL467-022/54/5-BC467-022/54/5-BC2016-09-01
00825114001886OWL467-022/100/5467-022/100/52016-09-01
00825114001893OWL467-022/100/5-BC467-022/100/5-BC2016-09-01
00825114001909OWL467-022/100/10-SC467-022/100/10-SC2016-09-01
00825114001930OWL466-018/100/5-SC466-018/100/5-SC2016-09-01
00825114001947OWL466-018/100/5-BC466-018/100/5-BC2016-09-01
00825114001954OWL466-018/100/10-SC466-018/100/10-SC2016-09-01
00825114001961OWL466-018/100/10-BC466-018/100/10-BC2016-09-01
00825114001978OWL466-018/150/10-SC466-018/150/10-SC2016-09-01
00825114001985OWL466-018/150/10-BC466-018/150/10-BC2016-09-01
00825114001992OWL467-022/100/10467-022/100/102016-09-01
00825114002005OWL467-022/100/2-SC467-022/100/2-SC2016-09-01
00825114002029OWL467-022/50/5-SC467-022/50/5-SC2016-09-01
00825114002050OWLDHC-022/50/5DHC-022/50/52016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21