FDA.reportPublic FDA data

ACE

Primary DI
00614950011643
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
04948001
Catalog number
04948001
Device description
BUR TREPHINE 35TL 2ID 2.8OD TI 18.5CL CA MRKS 8-10-13-15-18 INTERNAL IRRIGATION
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWKTREPHINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950011643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950011643006149500116436149500116430614950011643

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950031863BioPlugBH0054BH00542024-05-22
00614950031870BioStripBH00055BH000552024-05-22
00614950029525ACE400000140000012023-12-05
00614950029532ACE401500240150022023-12-05
00614950029549ACE400200740020072023-12-05
00614950029556ACE603901560390152023-12-05
00614950029563ACE603901660390162023-12-05
00614950029570ACE442305044230502023-12-05
00614950029587ACE090010209001022023-12-05
00614950029594Macan003333900333392023-12-05
00614950029600Macan526003552600352023-12-05
00614950029617Macan526003852600382023-12-05
00614950029624Macan526600052660002023-12-05
00614950029631Macan003334200333422023-12-05
00614950029648Macan526004552600452023-12-05
00614950029655Macan003333700333372023-12-05
00614950029662Macan526002652600262023-12-05
00614950029679ACE400520340052032023-12-05
00614950029686Macan003337600333762023-12-05
00614950029693Macan526002952600292023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663217477Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217484Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217491Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663217507Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-17
03662663134392C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHWK2025-12-03
03662663136327Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136334Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136341Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136358Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
03662663136365Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWK2025-12-03
10193489179583MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
10193489179590MEDLINEMEDLINE INDUSTRIES, INC.HWK2025-07-11
00850055649705INTREPED Extraction KitAuxano Medical LLCHWK2025-01-10
00190776384609MillenniumAvalign Technologies, Inc.HWK2024-08-22
00190776384616MillenniumAvalign Technologies, Inc.HWK2024-08-22
B756STR00107SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21