FDA.reportPublic FDA data

N/A

Primary DI
00841036021689
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-5270
Catalog number
02-5270
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
00841036021689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036021689008410360216898410360216890841036021689

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
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20757770457759Bausch + LombBausch & Lomb IncorporatedKAL2026-04-30
00190776419844MillenniumAvalign Technologies, Inc.KAL2026-04-15
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440096Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440102Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440119Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440126Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440133Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440164Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440324Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440331Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440348Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26
15060557440355Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDKAL2026-03-26