FDA.reportPublic FDA data

Raina Medical Devices

Primary DI
00850063380140
Brand
Raina Medical Devices
Company
ATLAS DISTRIBUTION AND LOGISTICS, LLC
Model
ADL-B1115
Catalog number
ADL-B1115
Device description
"STERILE Non-Stick Bipolar Forceps Bayonet - 11"" (28 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
00850063380140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063380140008500633801408500633801400850063380140

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
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13