FDA.reportPublic FDA data

Raina Medical Devices

Primary DI
00850063380058
Brand
Raina Medical Devices
Company
ATLAS DISTRIBUTION AND LOGISTICS, LLC
Model
ADL-B815
Catalog number
ADL-B815
Device description
"STERILE Non-Stick Bipolar Forceps Bayonet - 8"" (20.3 cm), 1.5 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
00850063380058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063380058008500633800588500633800580850063380058

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
00850063380034Raina Medical DevicesADL-B805ADL-B8052025-08-11
00850063380041Raina Medical DevicesADL-B810ADL-B8102025-08-11
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
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26