FDA.report

V. Mueller

Primary DI
10885403108990
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
RH330
Catalog number
RH330
Device description
V. Mueller ARBUCKLE SINUS PROBE DELICATE, MALLEABLE SILVER WORKING LENGTH 8" (20.3CM)
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KAKPROBE, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403108990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310899010885403108990

GMDN Terms

TermDefinition
Paranasal sinus probeA hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)323-9088Customer_Support@BD.com

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

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