FDA.report

SOLID CORTICAL TAP

Primary DI
00887868005992
Brand
SOLID CORTICAL TAP
Company
Biomet Orthopedics, LLC
Model
13570-70
Catalog number
1357070
Published
2017-04-07
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

Contact Domains

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887868005992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868005992008878680059928878680059920887868005992

GMDN Terms

TermDefinition
Bone tap, single-use, non-sterileA non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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