FDA.report

N/A

Primary DI
00841036027261
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
09-0142
Catalog number
09-0142
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
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841036027261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036027261008410360272618410360272610841036027261

GMDN Terms

TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. 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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00888233016902N/ASP-2482SP-24822020-06-16
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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

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B382SD9038721050Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD90390415L0Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD92011811070Surgical DirectSurgical Direct, Inc.EGN2026-03-02
G1493803706TBS DentalACME ENTERPRISE.EGN2026-03-02
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B382S3488110Surgical DirectSurgical Direct, Inc.EGN2026-02-25
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B382SD9035171020Surgical DirectSurgical Direct, Inc.EGN2026-02-16
B382SD9036541000Surgical DirectSurgical Direct, Inc.EGN2026-02-05
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B382S37921050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382S37921060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD59240Surgical DirectSurgical Direct, Inc.EGN2026-02-03
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B382SD90391117LH0Surgical DirectSurgical Direct, Inc.EGN2026-02-03
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B382SD9039831060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095200Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD909095230Surgical DirectSurgical Direct, Inc.EGN2026-02-03
D9283001200SCISSORS METZ 5 3/4" CRV DELICATE TCW.H. Holden, Inc.EGN2026-01-06