FDA.report

NA

Primary DI
03596010610119
Brand
NA
Company
Smith & Nephew, Inc.
Model
72201899
Catalog number
72201899
Device description
FOOTPRINT TENSION TUNER
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NBHACCESSORIES,ARTHROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010610119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010610119035960106101193596010610119

GMDN Terms

TermDefinition
Orthopaedic graft tensioner, reusableA hand-held, manual surgical instrument intended to be used during an open-surgery procedure [e.g., acromioclavicular joint repair, anterior cruciate ligament (ACL) reconstruction] to apply appropriate tension to a ligament graft/prosthesis, or flexible cord, to remove slack and facilitate adequate positioning of the device during implantation; it may also be used to apply tension to flexible instruments used during the procedure (e.g., graft sizer or gauge). Tension is applied to the graft after one end of the graft has been secured. The device is typically made of metal and in the form of a shaft with distal prongs. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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

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