FDA.report

Stryker

Primary DI
B504OM7028110
Brand
Stryker
Company
Provision
Model
702811
Published
2023-08-31
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
HWWCountersink

Product Code Classifications

CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B504OM7028110PrimaryHIBCC0

GMDN Terms

TermDefinition
Drilling power tool attachment, basicA 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 drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, 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

Contacts

PhoneEmail
541-480-7953customersupport@provisiondrs.com

Regulatory Flags

DUNS number
016889401
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B504AS42FRRRAZZ0Conmed Linvatec42FRR-RA-ZZ2017-12-01
B504AS9247A0Conmed Linvatec9247A2017-12-01
B504AS9297A0Conmed Linvatec9297A2017-12-01
B504AS9299A0Conmed Linvatec9299A2017-12-01
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10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277390072MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
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