FDA.report

NOPROFILE COUNTERSINK

Primary DI
00880304405530
Brand
NOPROFILE COUNTERSINK
Company
Biomet Orthopedics, LLC
Model
904308
Catalog number
904308
Published
2019-06-11
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

Contact Domains

Product Codes

CodeName
HWWCOUNTERSINK

Product Code Classifications

CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304405530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304405530008803044055308803044055300880304405530

GMDN Terms

TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

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
true
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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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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04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277390072MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
00810074306232Small Cannulated Countersink AO 125mmOsteocentric Technologies, Inc.HWW2024-12-06
00810111223416Depth gauge countersinkTreace Medical Concepts, Inc.HWW2024-11-19
04048266076830N/AMerete GmbHHWW2024-10-18
07612334236654NASynthes GmbHHWW2024-10-09
08800089451128Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHWW2024-09-25
00889795137098Phantom® Fibula Nail SystemPARAGON 28, INC.HWW2024-09-24
B504OM45300070StrykerProvisionHWW2024-08-26
B504OMAR8943050ArthrexProvisionHWW2024-08-13
B504OM127000040Extremity MedicalProvisionHWW2024-08-12
008100283950772.0/2.4 CountersinkTrilliant Surgical, LLCHWW2024-06-07
008100283950843.0/4.0 CountersinkTrilliant Surgical, LLCHWW2024-06-07
B504OM3108900SynthesProvisionHWW2024-05-17
B504OMP06N07110In2BonesProvisionHWW2024-05-17
B504OMP2091030000Paragon 28ProvisionHWW2024-05-17
B504OMA39370MedartisProvisionHWW2024-05-13
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