FDA.reportPublic FDA data

N/A

Primary DI
00841036007379
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
01-0301
Catalog number
01-0301
Published
2016-11-29
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036007379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036007379008410360073798410360073790841036007379

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwire/bracket ligatureA device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

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
true
Donation ID number
false
Contains natural rubber latex
true
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
00371347021028Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021035Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021042Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021059Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021066Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021073Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021080Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021097Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021103Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021110Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021127Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021134Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021141Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021158Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021165Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021172Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021189Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021196Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021202Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021219Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021226Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021233Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021240Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021257Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021264Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021271Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021288Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021295Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021301Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021318Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15