FDA.report

N/A

Primary DI
00841036027773
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0205
Catalog number
09-0205
Published
2018-08-22
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
false

Related Records

Contact Domains

Product Codes

CodeName
ECPINSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036027773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036027773008410360277738410360277730841036027773

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
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