FDA.report

N/A

Primary DI
B58203012850
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
B58203012850
Catalog number
B58203012850
Device description
B58203012850
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B58203012850PrimaryHIBCC0

GMDN Terms

TermDefinition
Chisel/osteotome blade handleA hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags

DUNS number
107043630
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B58206511500N/A6511506511502020-09-24
B58206513230N/A6513236513232020-09-24
B58206513300N/A6513306513302020-09-24
B58206542700N/A6542706542702020-09-24
B58206543800N/A6543806543802020-09-24
B5820655105N/A6551056551052020-09-24
B582065700PP0N/A065700PP065700PP2020-09-24
B582065705STRFA0N/A065705STRFA065705STRFA2020-09-24
B5820705000N/A70500705002020-09-24
B582070609STFRA0N/A070609STFRA070609STFRA2020-09-24
B5820800800N/A80080800802020-09-24
B5820800810N/A80081800812020-09-24
B582080090450N/A800904580090452020-09-24
B582080090620N/A800906280090622020-09-24
B582080091620N/A800916280091622020-09-24
B5820800950N/A80095800952020-09-24
B58208009910N/A8009918009912020-09-24
B58208009930N/A8009938009932020-09-24
B58208009940N/A8009948009942020-09-24
B58208009950N/A8009958009952020-09-24

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