FDA.reportPublic FDA data

N/A

Primary DI
00841036029074
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0378
Catalog number
09-0378
Published
2018-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036029074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036029074008410360290748410360290740841036029074

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESAM14447011STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447021STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447031STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447041STOMA®Storz am Mark GmbHEMJ2026-05-26
G149TBSB71010TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7720TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7730TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7740TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7750TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7760TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7770TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7780TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7790TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7800TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7810TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7820TBS BASICSACME ENTERPRISE.EMJ2026-05-22
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02