FDA.reportPublic FDA data

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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504TCOC46010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504GS80200Vericel80202026-07-20
B504GS80210Vericel80212026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20
B504OM4058890Biomet4058892026-07-20
B504OM41251470900Stryker4125-147-0902026-07-20
B504OM50711850Conmed Linvatec5071-1852026-07-20
B504OM51003372330Stryker5100-337-2332026-07-20
B504OM542022S0Stryker542022S2026-07-20
B504OM7024470Stryker7024472026-07-20
B504OMA37330MedartisA-37332026-07-20
B504OMAR1214L0ArthrexAR-1214L2026-07-20
B504OMAR1217L0ArthrexAR-1217L2026-07-20
B504OMAR14510ArthrexAR-14512026-07-20
B504OMCSS07247SQ0WrightCSS-072-47-SQ2026-07-20
B504OMKM166310260BrasselerKM166-310-262026-07-20
B504OMKM166310680BrasselerKM166-310-682026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776431136MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776431143MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776427160MillenniumAvalign Technologies, Inc.NBH2026-08-21
00190776427177MillenniumAvalign Technologies, Inc.NBH2026-08-21
00198506094170ELMED INCORPORATEDELMED INCORPORATEDNBH2026-08-18
07630345716743SportsMed InstrumentsMedacta International SANBH2026-08-17
07630345716750SportsMed InstrumentsMedacta International SANBH2026-08-17
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31