FDA.reportPublic FDA data

V. Mueller

Primary DI
20885403124430
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
AU05731-02
Catalog number
AU05731-02
Device description
EAR BLADES #71N MYRINGOTOMY LANCE TIP
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMFKNIFE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403124430PackageGS112In Commercial Distribution
10885403124433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540312443020885403124430
1088540312443310885403124433

GMDN Terms#

Term, Definition table
TermDefinition
Tympanotomy knife, reusableA hand-held manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

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Primary DI, Brand, Company table
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08681506800350SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-24
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
04046826114374Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftEMF2025-12-01
00190776404604MillenniumAvalign Technologies, Inc.EMF2025-07-10
00190776403058MillenniumAvalign Technologies, Inc.EMF2025-07-01
00190776403201MillenniumAvalign Technologies, Inc.EMF2025-07-01
08717903490280Humeca Silver knifeHumeca B.V.EMF2025-05-20
08717903490297Humeca Humby knifeHumeca B.V.EMF2025-05-20
08717903490303Humeca Cobbett knifeHumeca B.V.EMF2025-05-20
08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
00190776393137MillenniumAvalign Technologies, Inc.EMF2025-05-05
04049047000143GimmiGimmi GmbHEMF2025-04-16
04049047000297GimmiGimmi GmbHEMF2025-04-16
04049047000303GimmiGimmi GmbHEMF2025-04-16
04049047000358GimmiGimmi GmbHEMF2025-04-16
04049047000365GimmiGimmi GmbHEMF2025-04-16
04049047000402GimmiGimmi GmbHEMF2025-04-16
04049047000426GimmiGimmi GmbHEMF2025-04-16
04049047000457GimmiGimmi GmbHEMF2025-04-16
04049047000549GimmiGimmi GmbHEMF2025-04-16
04049047000853GimmiGimmi GmbHEMF2025-04-16
04049047000860GimmiGimmi GmbHEMF2025-04-16
04049047000877GimmiGimmi GmbHEMF2025-04-16
04049047000884GimmiGimmi GmbHEMF2025-04-16