FDA.report

ConMed

Primary DI
B504TCOC46010
Brand
ConMed
Company
Provision
Model
OC4601
Published
2024-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NBHAccessories, Arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B504TCOC46010PrimaryHIBCC0

GMDN Terms

TermDefinition
Endoscopic electrosurgical mucosal biopsy/resection setA collection of devices designed to be used during an endoscopic mucosal tissue biopsy and/or therapeutic resection procedure to: 1) isolate a specified section of mucosa using endoscopic suction and application of ligature bands; and 2) resect the lesion using monopolar electrosurgical energy. It consists of a ligation unit with distally-mounted bands and a flexible electrosurgical snare. Suction is applied to retract the tissue into the ligator cap, the ligature band(s) are then deployed, followed by electrosurgical resection of the tissue with the snare. Disposable devices for histological sample processing (e.g., biowraps) may be included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags

DUNS number
016889401
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B504AS42FRRRAZZ0Conmed Linvatec42FRR-RA-ZZ2017-12-01
B504AS9247A0Conmed Linvatec9247A2017-12-01
B504AS9297A0Conmed Linvatec9297A2017-12-01
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