FDA.reportPublic FDA data

CONCEPT

Primary DI
20845854031268
Brand
CONCEPT
Company
Conmed Corporation
Model
C6811
Catalog number
C6811
Device description
CONCEPT ROTARY SCISSOR, 20 DEGREE, RIGHT
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854031268Direct MarkingGS10
10845854031261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585403126820845854031268
1084585403126110845854031261

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic grasping forceps, reusableA rigid hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument; it is not an electrosurgical instrument. It is typically made of high-grade stainless steel and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle20degree

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
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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10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
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