FDA.reportPublic FDA data

N/A

Primary DI
00841036027766
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0204
Catalog number
09-0204
Published
2018-08-22
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
ECPINSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036027766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036027766008410360277668410360277660841036027766

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic ligature directorA hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. 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
G149TBSB1360TBS BASICSACME ENTERPRISE.ECP2026-05-20
G149TBSB1350TBS BASICSACME ENTERPRISE.ECP2026-05-18
00840479203614ULTRA VIOLET MINI LIGHTRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203669SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203270MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203287MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203348SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203447SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479202112MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202143MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202150MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202167MIXING ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479201528SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-05
00840479200576SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200583WHITE SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200590LIGHT IMPERVIOUS MIX WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200606SUPERFINE MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200651SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
0084047920070521 GAUGE BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200712"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200729"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200743ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200972BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200354WHITE MIXING WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200361CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200385CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200866BRUSH HANDLE ASSORTEDRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479203454SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
0084047920349215 GAUGE TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479209814SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20