FDA.reportPublic FDA data

DYONICS

Primary DI
00885554034493
Brand
DYONICS
Company
Smith & Nephew, Inc.
Model
72204159
Catalog number
72204159
Device description
DYONICS LG OSC BLADE 19.5 X 86 X 0.9MM
Published
2016-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885554034497PackageGS16In Commercial Distribution
00885554034493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088555403449720885554034497
00885554034493008855540344938855540344930885554034493

GMDN Terms#

Term, Definition table
TermDefinition
Oscillating surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90? angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867614956Arthrex®ARTHREX, INC.GFA2026-05-25
08404535025156LARGE BONE BLADESPeter Brasseler Holdings, LLCGFA2026-03-23
B504OM4515700130DePuy MitekProvisionGFA2026-03-19
B504OM50715940Conmed LinvatecProvisionGFA2026-03-19
B504OMDC119090180Conmed LinvatecProvisionGFA2026-03-19
00810111225366Saw BladeTreace Medical Concepts, Inc.GFA2026-01-26
00810111225342Saw BladeTreace Medical Concepts, Inc.GFA2026-01-07
00810111225335Saw BladeTreace Medical Concepts, Inc.GFA2025-12-18
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIGFA2025-12-12
B39062901120331Reprocessed 3mm Straight Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
16974940305963endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305970endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305987endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305994endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306007endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306014endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306021endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306038endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306048endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306055endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306069endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306076endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306083endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306090endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306106endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306113endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306120endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306137endophixSuzhou Endophix Co., Ltd.GFA2025-12-05