FDA.reportPublic FDA data

NA

Primary DI
03596010555960
Brand
NA
Company
Smith & Nephew, Inc.
Model
7211010S
Catalog number
7211010S
Device description
DYONICS 25 FLUID MANAGEMENT CONTROL UNIT SERVICE REPLACEMENT CONTROL UNIT ONLY
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXARTHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010555960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010555960035960105559603596010555960

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic irrigation/insufflation systemA mains electricity (AC-powered) device assembly designed to provide controlled distention and irrigation (expansion by pressure and continual flushing) of the tissue and space around a joint where arthroscopy is being performed (e.g., the knee or shoulder joint). This is achieved by filling the cavity with a sterile fluid that is pumped into the wound by the system's pump(s) and distends the tissue around the site to improve visualization and enlarge the surgical field. Suction may also be applied by the system to assist in the removal of the surgically-resected bone, cartilage, and other tissue/debris from the site.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
10845854041116POWERPROConmed CorporationHRX2026-03-24
04056702011970PUREVUE™ FMSW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012137Tube set inflow 4-Spike adaptorW.O.M. World of Medicine GmbHHRX2026-03-10
00763000956028Tubing SetMEDTRONIC XOMED, INC.HRX2026-02-14
B382SD401290Surgical DirectSurgical Direct, Inc.HRX2026-02-09
B382SD401490Surgical DirectSurgical Direct, Inc.HRX2026-02-09
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHRX2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHRX2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHRX2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHRX2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHRX2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHRX2025-12-17
06938695521026DrillShanghai Kinetic Medical Co., Ltd.HRX2025-12-09
08800038029323SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HRX2025-09-24