FDA.report

NA

Primary DI
03596010469144
Brand
NA
Company
Smith & Nephew, Inc.
Model
7209214
Catalog number
7209214
Device description
SLOTTED GRAFT SIZING BLOCK
Published
2015-08-30
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

Related Records

Contact Domains

Product Codes

CodeName
HWTTEMPLATE

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010469144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010469144035960104691443596010469144

GMDN Terms

TermDefinition
Graft sizing blockA non-sterile device designed for the determination of the graft size (e.g., a patellar tendon graft) taken from the patient to be used for an appropriate tunnel preparation and identify the tunnel size for anterior cruciate ligament (ACL) reconstruction. It typically consists of a block containing a series of graduated holes with denoted size and graduations of measurement along and edge or edges. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)821-5700gudid@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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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