FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403010255
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
AU12995
Catalog number
AU12995
Device description
V. Mueller MCCABE PERFORATION RASP BLADE ANGLED 120DEG, RASP INSIDE OF BLADE, SQUARE SOLID HANDLE OVERALL LENGTH 6-1/4" (15.9CM)
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
JYYRASP, EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403010255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540301025510885403010255

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
09348811112798INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-12-02
09348811112804INKAThe Trustee for KAISER FAMILY TRUSTJYY2025-11-24
00757770420384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-05
00757770404384Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770422722Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00757770435647Bausch + LombBausch & Lomb IncorporatedJYY2025-08-04
00887482035160Symmetry Surgical®SYMMETRY SURGICAL INC.JYY2024-08-12
00887482120057Symmetry Surgical®SYMMETRY SURGICAL INC.JYY2024-08-12
00840183525958BR Surgical, LLCBR Surgical, LLCJYY2024-06-03
G586E7773430Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
G586E7773450Novo SurgicalNOVO SURGICAL, INC.JYY2023-12-18
00190776324308MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324346MillenniumAvalign Technologies, Inc.JYY2023-11-13
00190776324292MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776324339MILLENNIUMAvalign Technologies, Inc.JYY2023-09-28
00190776376529AvalignAvalign Technologies, Inc.JYY2023-09-28
00810123201525Adler Instrument CompanyAdler, Inc.JYY2023-03-15
00840319742624Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742631Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742648Hayden MedicalHayden Medical, Inc.JYY2023-03-14
00840319742655Hayden MedicalHayden Medical, Inc.JYY2023-03-14
54026704807715PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807777PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807739PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807753PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807746PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807722PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
54026704807760PILLINGTELEFLEX INCORPORATEDJYY2022-12-08
00842331174773Novo Surgical Inc. NOVO SURGICAL, INC.JYY2022-11-14
00842331174780Novo Surgical Inc. NOVO SURGICAL, INC.JYY2022-11-14