FDA.report

GEO Single Use Driver Handle

Primary DI
B471200800000
Brand
GEO Single Use Driver Handle
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
20080000
Device description
Driver Handle AO Fixed Straight Single Use
Published
2020-10-21
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B471200800000PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical torque wrench, single-useA sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use 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
true
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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