FDA.report

V. Mueller

Primary DI
10885403189487
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
SU410-01
Catalog number
SU410-01
Device description
V. Mueller HEMORRHOIDAL LIGATOR WITH SUCTION
Published
2017-10-17
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
FHNLigator, hemorrhoidal

Product Code Classifications

CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885403189487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088540318948710885403189487

GMDN Terms

TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. 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
false
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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