FDA.reportPublic FDA data

N/A

Primary DI
00841036030452
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0595
Catalog number
09-0595
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036030452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036030452008410360304528410360304520841036030452

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002567Mirror Front Surface Simple Stem #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002574Mirror Front Surface Cone Socket #5The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002581Mirror Front Surface Simple Stem #5The Atlanta Dental Supply CompanyEAX2022-11-23
10818207024203Vista RSS Mirror HandleVista DentalEAX2022-09-01
10818207024210Vista RCS Mirror HandleVista DentalEAX2022-09-01
10818207024227Vista OCS Mirror HandleVista DentalEAX2022-09-01
10843717102592Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102608Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102615Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
10843717102622Midway SelectMIDWAY DENTAL SUPPLY, LLCEAX2022-08-26
G1577072350PomeePOMEE CORPORATIONEAX2021-12-30
10889950015381HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015398HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015404HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015411HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015428HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015435HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015442HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015459HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12
10889950015466HU-FRIEDYHU-FRIEDY MFG. CO., LLCEAX2020-11-12