FDA.report

ACE

Primary DI
00614950011964
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
04949501S
Catalog number
04949501S
Device description
BUR TREPHINE 49TL 6ID 6.9OD 15.7CL STRYKER NOTCH MRKS 8-10-13-15 TI
Published
2019-10-12
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
false

Related Records

Product Codes

CodeName
HWKTREPHINE

Product Code Classifications

CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950011964PrimaryGS10

GMDN Terms

TermDefinition
Titanium dental burA rotary cutting device, the working end of which is made from titanium (Ti), and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It can also be used to cut metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter6.9Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)441-3100ritaknight@acesurgical.com

Regulatory Flags

DUNS number
042763706
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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00614950029594Macan003333900333392023-12-05
00614950029600Macan526003552600352023-12-05
00614950029617Macan526003852600382023-12-05
00614950029624Macan526600052660002023-12-05
00614950029631Macan003334200333422023-12-05
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00614950029655Macan003333700333372023-12-05
00614950029662Macan526002652600262023-12-05
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00614950029686Macan003337600333762023-12-05
00614950029693Macan526002952600292023-12-05

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