FDA.report

3M™ Unitek™ MBT™

Primary DI
00652221031228
Brand
3M™ Unitek™ MBT™
Company
3M UNITEK CORPORATION
Model
119-714
Catalog number
119-714
Device description
Unitek(TM) Gemini Bracket MBT(TM) UR1 17T/4A .022 10/Pk
Published
2018-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00652221031228PrimaryGS10
80652221031224Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221031228006522210312286522210312280652221031228
8065222103122480652221031224

GMDN Terms

TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)423-45883Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
008256356
Device count
10
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
006522213072483M™ Clarity™359-820359-8202024-11-22
006522213072553M™ Clarity™359-821359-8212024-11-22
006522213072623M™ Clarity™359-822359-8222024-11-22
006522213072793M™ Clarity™359-823359-8232024-11-22
006522213072863M™ Clarity™359-830359-8302024-11-22
006522213072933M™ Clarity™359-831359-8312024-11-22
006522213073093M™ Clarity™359-832359-8322024-11-22
006522213073163M™ Clarity™359-833359-8332024-11-22
006522213073233M™ Clarity™359-824359-8242024-11-22
006522213073303M™ Clarity™359-825359-8252024-11-22
006522213073473M™ Clarity™359-826359-8262024-11-22
006522213073543M™ Clarity™359-827359-8272024-11-22
006522213073613M™ Clarity™359-834359-8342024-11-22
006522213073783M™ Clarity™359-835359-8352024-11-22
006522213073853M™ Clarity™359-836359-8362024-11-22
006522213073923M™ Clarity™359-837359-8372024-11-22
106058610857693M™EX-1009795EX-10097952024-03-28
806522211619073M™ Unitek™504-319504-3192022-12-08
006522213033563M™ Unitek™404-116404-1162023-06-22
006522213033633M™ Unitek™404-126404-1262023-06-22

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