FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403010545
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
AU13622
Catalog number
AU13622
Device description
TABB MYRINGOPLASTY KNIFE 1.3MM BLADES ANGLED 90° & 115° OVERALL LENGTH 6-1/4" (15.8CM)
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
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403010545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540301054510885403010545

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
Moist Heat or Steam Sterilization

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
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26
00757770636235Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770668564Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770672103Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682584Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682591Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683611Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683628Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770404001Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770405206Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407590Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407712Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770408634Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770409723Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770410767Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770413980Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770414963Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05