FDA.report

NA

Primary DI
00886385017136
Brand
NA
Company
Stryker Trauma SA
Model
905-0064
Catalog number
905-0064
Device description
Barrel Hole Twist Drill w/ Stop
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NTGProsthesis, ankle, uncemented, non-constrained

Product Code Classifications

CodeDeviceSpecialtyClass
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886385017136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385017136008863850171368863850171360886385017136

GMDN Terms

TermDefinition
Fluted surgical drill bit, single-use, non-sterileA non-sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
481999654
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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