FDA.report

V. Mueller

Primary DI
10885403109195
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
RH550-101
Catalog number
RH550-101
Device description
STAMMBERGER ANTRUM PUNCH UPSIDE DOWN, BACKWARD CUTTING WORKING LENGTH 4-1/8" (10.5CM)
Published
2018-09-14
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

Related Records

Contact Domains

Product Codes

CodeName
KTFPUNCH, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403109195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540310919510885403109195

GMDN Terms

TermDefinition
ENT punchA general-purpose, manual surgical instrument designed for taking a soft tissue or bone sample during ear/nose/throat (ENT) surgery. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol-grip or ring handles. The working end terminates with sharp, profiled cutting jaws that close over the tissue when the handles are squeezed together cutting through it. It is available in various sizes and designs and is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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