FDA.report

V. Mueller

Primary DI
10885403114427
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
RH3520
Catalog number
RH3520
Device description
V. Mueller WELLAMINSKI ANTRUM PERFORATOR BLADE DIAMETER 6MM OVERALL LENGTH 6-1/2" (16.5CM)
Published
2018-09-10
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
KATPERFORATOR, ANTRUM

Product Code Classifications

CodeDeviceSpecialtyClass
KATPerforator, AntrumEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403114427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540311442710885403114427

GMDN Terms

TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). 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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04038653051472AESCULAPAesculap AGKAT2020-05-20
04046964073090AESCULAPAesculap AGKAT2020-04-24
04046964073205AESCULAPAesculap AGKAT2020-04-24
04046964073212AESCULAPAesculap AGKAT2020-04-24
04046964073229AESCULAPAesculap AGKAT2020-04-24
04046964073236AESCULAPAesculap AGKAT2020-04-24
04046964073243AESCULAPAesculap AGKAT2020-04-24
04038653207251AESCULAPAesculap AGKAT2020-04-23
04038653176373AESCULAPAesculap AGKAT2020-04-22
04038653176458AESCULAPAesculap AGKAT2020-04-22
04038653176465AESCULAPAesculap AGKAT2020-04-22
04038653176472AESCULAPAesculap AGKAT2020-04-22
10885403114366V. MuellerCAREFUSION 2200, INCKAT2020-04-15
10885403114335V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114328V. MuellerCAREFUSION 2200, INCKAT2018-09-10
00841036021511N/ABIOMET MICROFIXATION, INCKAT2017-06-16