FDA.report

NA

Primary DI
20845854025465
Brand
NA
Company
Conmed Corporation
Model
8720
Catalog number
8720
Device description
9MM RECTANGULAR PATELLAR TENDOR GRAFT TEMPLATE
Published
2016-09-24
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
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854025465Direct MarkingGS10
00845854025461PrimaryGS10
10845854025468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585402546520845854025465
00845854025461008458540254618458540254610845854025461
1084585402546810845854025468

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
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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