FDA.reportPublic FDA data

N/A

Primary DI
00841036021702
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-5280
Catalog number
02-5280
Published
2017-06-16
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
KALRETRACTOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036021702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036021702008410360217028410360217020841036021702

GMDN Terms#

Term, Definition table
TermDefinition
ENT retractorA surgical instrument for separating or drawing aside the margins of a surgical incision made during ear/nose/throat (ENT) surgery or various structures of these anatomical locations. It can have various designs, e.g., double or single-ended with a flat or curved, single or split, hook-like blade, or have a pointed hook formed at various angles. It is made of high-grade stainless steel. 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
00841036019112N/A02-008302-00832017-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
04054462156498evonosevonos GmbH & Co. KGKAL2026-08-26
04054462156504evonosevonos GmbH & Co. KGKAL2026-08-26
04054462913039evonosevonos GmbH & Co. KGKAL2026-08-26
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913237evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915835evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915842evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915859evonosevonos GmbH & Co. KGKAL2026-08-17