FDA.report

SENTINEL

Primary DI
20845854018283
Brand
SENTINEL
Company
Conmed Corporation
Model
S8580
Catalog number
S8580
Device description
8 x 229mm (9") SENTINEL Cannulated Drill Bit
Published
2021-10-13
Public version status
New
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
GFGBIT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854018283PackageGS11In Commercial Distribution
10845854018286PrimaryGS10
00845854018289Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585401828320845854018283
1084585401828610845854018286
00845854018289008458540182898458540182890845854018289

GMDN Terms

TermDefinition
Wire-driving power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a wire driving/insertion function when an appropriate orthopaedic wire is inserted, e.g., Kirschner wires or K-Wires (thin pins that are pointed for self-drilling). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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