FDA.report

NA

Primary DI
30845854018303
Brand
NA
Company
Conmed Corporation
Model
21.1001
Catalog number
21.1001
Device description
3.5MM X 130MM MINI-PROBE, STRAIGHT
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

Related Records

Contact Domains

Product Codes

CodeName
HXBPROBE

Product Code Classifications

CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854018303Direct MarkingGS10
10845854018309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084585401830330845854018303
1084585401830910845854018309

GMDN Terms

TermDefinition
Arthroscopic probeA hand-held manual surgical instrument designed to be inserted through an arthroscope to explore, measure, and/or perform therapeutic procedures within a joint. This is a reusable device.

Device Sizes

TypeValueUnit
Length130Millimeter
Width3.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true
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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