FDA.reportPublic FDA data

Dynablator™

Primary DI
00859273007052
Brand
Dynablator™
Company
RELIGN CORPORATION
Model
R-10005
Catalog number
R-10005
Device description
RF probe, disposable
Published
2020-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162770000Relign SystemRelign Corporation2017-01-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859273007059PackageGS14In Commercial Distribution
00859273007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085927300705910859273007059
00859273007052008592730070528592730070520859273007052

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Contacts#

Phone, Email table
PhoneEmail
(866) 608-0131customer.service@religncorp.com

Regulatory Flags#

DUNS number
080031617
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024681101STANDARD SHAVER™ 4.2MMR10029R100292025-10-07
008890246811184.2MM CURVED STANDARD SHAVER™R10030R100302025-10-07
008592730070833-in-1 SHAVER™ 4.2mmR-10008R-100082020-07-17
00859273007120Standard Shaver 3.4mmR-10012R-100122021-03-05
008592730071443-in-1 SHAVER™ 5.0mmR-10014R-100142020-02-20
00859273007175Exoflow™R-10017R-100172020-02-20
00859273007243Curved Standard Shaver 3.4mmR-10024R-100242021-03-05
00859273007250Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
00859273007267Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16
00859273007274Curved Dynablator® XLR-10027R-100272024-12-18
00859273007212Standard Burr 5.0mmR-10021R-100212020-10-14
00859273007236Tricera™ Handpiece, AutoclavableR-10023R-100232020-08-20
00859273007014Tricera™ ControllerR-10001R-100012020-02-20
00859273007021Tricera™ HandpieceR-10002R-100022020-02-20
00859273007038Veriflow™R-10003R-100032020-02-20
00859273007113Tricera™ Handpiece, AutoclavableR-10011R-100112020-02-20
10859273007271Curved Dynablator® XLR-10027R-100272024-12-18
10859273007257Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
10859273007264Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16
10859273007127Standard Shaver 3.4mmR-10012R-100122021-03-05

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Primary DI, Brand, Company table
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07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
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07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
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00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
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