FDA.report

XACTPIN

Primary DI
10845854041741
Brand
XACTPIN
Company
Conmed Corporation
Model
C8677S
Catalog number
C8677S
Device description
XACTPIN Graft Passing Guide Pin, 2.4mm x 43mm, Sterile
Published
2021-10-12
Public version status
New
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
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845854041741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084585404174110845854041741

GMDN Terms

TermDefinition
Orthopaedic graft guideA device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior cruciate ligament (ACL) reconstruction surgery]. It is typically tubular-shaped, made of sturdy materials (e.g., stainless steel, hard plastic) and comes in varying sizes. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
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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