FDA.reportPublic FDA data

EMERGE MEDICAL & Design

Primary DI
00886020016135
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
03.010.089.EM
Catalog number
03.010.089.EM
Device description
4.5MM CANNULATED DRILL BIT/ JC/WITH 135MM STOP/165MM
Published
2015-07-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886020016135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020016135008860200161358860200161350886020016135

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078642955
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886020026417EMERGE MEDICAL & Design319.293.EM319.293.EM2015-07-08
00886020026431EMERGE MEDICAL & Design319.292.EM319.292.EM2015-07-08
00886020026455EMERGE MEDICAL & Design319.38.EM319.38.EM2015-07-08
00886020026479EMERGE MEDICAL & Design319.35.EM319.35.EM2015-07-08
00886020026554EMERGE MEDICAL & Design319.46.EM319.46.EM2015-07-08
00886020026899EMERGE MEDICAL & Design309.501.EM309.501.EM2015-07-08
00886020008109EMERGE MEDICAL & Design211.841.EM211.841.EM2015-07-07
00886020008116EMERGE MEDICAL & Design211.842.EM211.842.EM2015-07-07
00886020008123EMERGE MEDICAL & Design211.843.EM211.843.EM2015-07-07
00886020008130EMERGE MEDICAL & Design211.844.EM211.844.EM2015-07-07
00886020008147EMERGE MEDICAL & Design211.845.EM211.845.EM2015-07-07
00886020008154EMERGE MEDICAL & Design211.846.EM211.846.EM2015-07-07
00886020008161EMERGE MEDICAL & Design211.847.EM211.847.EM2015-07-07
00886020008178EMERGE MEDICAL & Design211.848.EM211.848.EM2015-07-07
00886020008185EMERGE MEDICAL & Design211.849.EM211.849.EM2015-07-07
00886020008284EMERGE MEDICAL & Design211.810.EM211.810.EM2015-07-07
00886020008291EMERGE MEDICAL & Design211.811.EM211.811.EM2015-07-07
00886020008307EMERGE MEDICAL & Design211.812.EM211.812.EM2015-07-07
00886020008314EMERGE MEDICAL & Design211.813.EM211.813.EM2015-07-07
00886020008321EMERGE MEDICAL & Design211.814.EM211.814.EM2015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017461A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017478A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017485A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017492A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017508A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017515A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017522A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017539A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017546A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017560A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017577A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04