FDA.reportPublic FDA data

Raina Medical Devices

Primary DI
00850063380034
Brand
Raina Medical Devices
Company
ATLAS DISTRIBUTION AND LOGISTICS, LLC
Model
ADL-B805
Catalog number
ADL-B805
Device description
"STERILE Non-Stick Bipolar Forceps Bayonet - 8"" (20.3 cm), 0.5 mm Tip"
Published
2025-08-11
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182773000Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forcepsFaulhaber Pinzetten Ohg2019-10-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063380034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063380034008500633800348500633800340850063380034

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7044437185julia.ludwig@atlasdistributionnc.com

Regulatory Flags#

DUNS number
130328134
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
00850063380003Raina Medical DevicesADL-J425SADL-J425S2025-08-11
00850063380010Raina Medical DevicesADL-B47510ADL-B475102025-08-11
00850063380027Raina Medical DevicesADL-B6510ADL-B65102025-08-11
00850063380041Raina Medical DevicesADL-B810ADL-B8102025-08-11
00850063380058Raina Medical DevicesADL-B815ADL-B8152025-08-11
00850063380065Raina Medical DevicesADL-B905ADL-B9052025-08-11
00850063380072Raina Medical DevicesADL-B910ADL-B9102025-08-11
00850063380089Raina Medical DevicesADL-B915ADL-B9152025-08-11
00850063380096Raina Medical DevicesADL-B1005ADL-B10052025-08-11
00850063380102Raina Medical DevicesADL-B1010ADL-B10102025-08-11
00850063380119Raina Medical DevicesADL-B1015ADL-B10152025-08-11
00850063380126Raina Medical DevicesADL-B1105ADL-B11052025-08-11
00850063380133Raina Medical DevicesADL-B1110ADL-B11102025-08-11
00850063380140Raina Medical DevicesADL-B1115ADL-B11152025-08-11
00850063380157Raina Medical DevicesADL-B1205ADL-B12052025-08-11
00850063380164Raina Medical DevicesADL-B1210ADL-B12102025-08-11
00850063380171Raina Medical DevicesADL-B815IADL-B815I2025-08-11
00850063380188Raina Medical DevicesADL-B915IADL-B915I2025-08-11
00850063380195Raina Medical DevicesADL-C6510ADL-C65102025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03