FDA.report

NA

Primary DI
10886982292469
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
05.001.128
Catalog number
05001128
Device description
DRILL/BURR ATTACHMENT 16-1 STRAIGHT-ROUND SHAFT- EPD/APD
Published
2021-01-21
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

Product Codes

CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications

CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10886982292469PrimaryGS10

GMDN Terms

TermDefinition
Burring 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 burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
832637081
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10886982293251NA04.045.234040452342025-01-31
10886982293268NA04.045.236040452362025-01-31
10886982293275NA04.045.238040452382025-01-31
10886982293282NA04.045.240040452402025-01-31
10886982293299NA04.045.242040452422025-01-31
10886982293305NA04.045.244040452442025-01-31
10886982293312NA04.045.246040452462025-01-31
10886982293329NA04.045.248040452482025-01-31
10886982293336NA04.045.250040452502025-01-31
10886982293343NA04.045.252040452522025-01-31
10886982293350NA04.045.254040452542025-01-31
10886982293367NA04.045.256040452562025-01-31

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