FDA.report

N/A

Primary DI
00841036029692
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0461
Catalog number
09-0461
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
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036029692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036029692008410360296928410360296920841036029692

GMDN Terms

TermDefinition
Tooth extraction forcepsA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. 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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00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

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