FDA.report

EMERGE MEDICAL & Design

Primary DI
00886020016319
Brand
EMERGE MEDICAL & Design
Company
EMERGE MEDICAL, INC.
Model
357.099.EM
Catalog number
357.099.EM
Device description
5.0MM THREE-FLUTED DRILL BIT QC 330MM/100MM CALIB
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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00886020016319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00886020016319008860200163198860200163190886020016319

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA 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, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078642955
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

Primary DIBrandModelCatalogPublished
00886020026424EMERGE MEDICAL & Design319.289.EM319.289.EM2015-07-08
00886020026448EMERGE MEDICAL & Design319.291.EM319.291.EM2015-07-08
00886020026462EMERGE MEDICAL & Design319.25.EM319.25.EM2015-07-08
00886020026493EMERGE MEDICAL & Design319.26.EM319.26.EM2015-07-08
00886020026578EMERGE MEDICAL & Design319.24.EM319.24.EM2015-07-08
00886020028916EMERGE MEDICAL & Design398.95.EM398.95.EM2015-07-08
00886020028923EMERGE MEDICAL & Design399.091.EM399.091.EM2015-07-08
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
00886020026677EMERGE MEDICAL & Design319.70.EM319.70.EM2015-07-08
00886020026684EMERGE MEDICAL & Design311.689.EM311.689.EM2015-07-08
00886020026998EMERGE MEDICAL & Design319.703.EM319.703.EM2015-07-08
00886020028602EMERGE MEDICAL & Design319.004.EM319.004.EM2015-07-08
00886020028619EMERGE MEDICAL & Design319.006.EM319.006.EM2015-07-08
00886020028657EMERGE MEDICAL & Design323.025.EM323.025.EM2015-07-08
00886020030308EMERGE MEDICAL & Design319.01.EM319.01.EM2015-07-08

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