FDA.report

NA

Primary DI
20845854041144
Brand
NA
Company
Conmed Corporation
Model
83100
Catalog number
83100
Device description
ARTHROSCOPY TUBING SET, QTY 5
Published
2016-09-24
Public version status
Update
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
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854041144PackageGS15In Commercial Distribution
10845854041147PrimaryGS10
00845854041140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585404114420845854041144
1084585404114710845854041147
00845854041140008458540411408458540411400845854041140

GMDN Terms

TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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