FDA.report

DYONICS 25

Primary DI
03596010550088
Brand
DYONICS 25
Company
Smith & Nephew, Inc.
Model
72200226
Catalog number
72200226
Device description
KIT DYONICS 25 SWEDISH
Published
2015-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010550088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010550088035960105500883596010550088

GMDN Terms

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

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
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

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