FDA.reportPublic FDA data

N/A

Primary DI
00841036018764
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-0027
Catalog number
02-0027
Published
2017-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBMDISSECTOR, TONSIL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBMDissector, TonsilEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036018764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036018764008410360187648410360187640841036018764

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil dissector, reusableA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00757770411443Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770421091Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770427116Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
00757770435593Bausch + LombBausch & Lomb IncorporatedKBM2025-07-29
04049047679776GimmiGimmi GmbHKBM2025-04-16
00194613120344MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2025-03-21
00194613061692MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2024-08-15
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00194613094973MSI Precision Specialty InstrumentsMed Saver, Inc.KBM2024-08-15
00840183512309BR Surgical, LLCBR Surgical, LLCKBM2024-06-10
00840183512484BR Surgical, LLCBR Surgical, LLCKBM2024-06-10
00887482049198Symmetry LillieASPEN SURGICAL PRODUCTS, INC.KBM2022-10-13
00887482122839Symmetry HurdASPEN SURGICAL PRODUCTS, INC.KBM2022-10-13
04046826131128MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBM2020-09-24
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04046955088461AESCULAPAESCULAP, INC.KBM2020-08-03
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04038653179985AESCULAPAesculap AGKBM2020-04-22
04038653180004AESCULAPAesculap AGKBM2020-04-22
04038653053551AESCULAPAesculap AGKBM2020-04-20
04038653053568AESCULAPAesculap AGKBM2020-04-20