FDA.reportPublic FDA data

DYONICS

Primary DI
03596010655899
Brand
DYONICS
Company
Smith & Nephew, Inc.
Model
72203127
Catalog number
72203127
Device description
HIGH VISIBILITY SHEATH 5.5 MM ABRADER BURR
Published
2015-08-29
Public version status
Update
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
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010655893PackageGS13In Commercial Distribution
03596010655899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601065589323596010655893
03596010655899035960106558993596010655899

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, single-useA cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260472037TRAUSSaeshin Precision Co., Ltd.HAB2026-05-07
08809260471924TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471931TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471948TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471955TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471962TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471979TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471986TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471993TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472006TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472013TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472020TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473041TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473058TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473065TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473072TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473089TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473096TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473102TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
30653405990738Hall® Titan™Conmed CorporationHAB2025-12-29
30653405990745Hall® Titan™Conmed CorporationHAB2025-12-29
10653405005513HALLConmed CorporationHAB2023-12-04
10653405005711HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005728HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005735HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005742HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005759HALL MICROFREEConmed CorporationHAB2023-10-12
00885556826676First Choice DRUJ SystemSmith & Nephew, Inc.HAB2023-08-02
00885556856840Ascension MCP Joint ReplacementSmith & Nephew, Inc.HAB2023-08-02
00885556857663NuGrip CMCSmith & Nephew, Inc.HAB2023-08-02