FDA.report

GEO Staple System

Primary DI
B471240000010
Brand
GEO Staple System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
24000001
Device description
Staple Tamp, Small
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

Contact Domains

Product Codes

CodeName
HXGTAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B471240000010PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic bone staple driverA hand-held surgical instrument designed to impart force on a bone staple, or on another instrument, to insert the bone staple typically into fractured bone. The distal end is typically shaped to mate with the bone staple. The proximal end is designed to absorb and transmit an impact force. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

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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B471110235420EPS Plating System Screw110235422022-01-10
B471110235440EPS Plating System Screw110235442022-01-10
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B471110235480EPS Plating System Screw110235482022-01-10
B471110235500EPS Plating System Screw110235502022-01-10
B471110235550EPS Plating System Screw110235552022-01-10
B471110235600EPS Plating System Screw110235602022-01-10
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B471110340440EPS Plating System Screw110340442022-01-10
B471110340460EPS Plating System Screw110340462022-01-10
B471110340480EPS Plating System Screw110340482022-01-10
B471110340500EPS Plating System Screw110340502022-01-10
B471110340550EPS Plating System Screw110340552022-01-10

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