FDA.report

NA

Primary DI
30845854025523
Brand
NA
Company
Conmed Corporation
Model
8733
Catalog number
8733
Device description
2MM (5/64 IN) TWIST DRILL WITH STOP, 4 EA
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
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854025523Direct MarkingGS10
10845854025529PackageGS14In Commercial Distribution
20845854025526PrimaryGS10
00845854025522Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585402552330845854025523
1084585402552910845854025529
2084585402552620845854025526
00845854025522008458540255228458540255220845854025522

GMDN Terms

TermDefinition
Manual surgical rotary handpieceA manually-powered, hand-held, surgical device intended to be used to generate a rotary motion to an endpiece during a surgical procedure for e.g., cutting, sculpting, trepanning, drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon holding the top of the brace steady whilst rotating it with horizontal crankshaft-like movements with the other hand; or 2) a drill powered by the rotation of a side-mounted, handle; it may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Device Sizes

TypeValueUnit
Length0.078125Inch
Length2Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
071595540
Device count
4
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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