FDA.report

GEO Staple System

Primary DI
B471140202000
Brand
GEO Staple System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
14020200
Device description
Staple 20mmx20mmx20mm, Symmetric Smooth Leg, Nitinol
Published
2019-05-10
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

Product Codes

CodeName
JDRStaple, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B471140202000PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Width20Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)436-2278GEOSupportCenter@gramercyortho.com

Regulatory Flags

DUNS number
080068420
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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