FDA.reportPublic FDA data

N/A

Primary DI
B582801510120
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
8015101/2
Catalog number
8015101/2
Device description
ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B582801510120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags#

DUNS number
107043630
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B58208011750N/A080117508011752020-09-24
B58208011770N/A080117708011772020-09-24
B58208011810N/A080118108011812020-09-24
B58208012000N/A080120008012002020-09-24
B58208012050N/A080120508012052020-09-24
B58208012120N/A080121208012122020-09-24
B58208012130N/A080121308012132020-09-24
B58208012160N/A080121608012162020-09-24
B582081899N/A0818990818992020-09-24
B58208349610N/A08349610083496102020-09-24
B5820834962N/A083496208349622020-09-24
B5820834963N/A083496308349632020-09-24
B5820834964N/A083496408349642020-09-24
B5820834965N/A083496508349652020-09-24
B5820834966N/A083496608349662020-09-24
B5820834968N/A083496808349682020-09-24
B582080140720N/A08014072080140722020-09-24
B582080141040N/A08014104080141042020-09-24
B582080BYRDCURETTE20N/A080BYRD CURETTE2080BYRD CURETTE22020-09-24
B582080BYRDCURETTE200N/A080BYRD CURETTE2/0080BYRD CURETTE202020-09-24

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