Primary Device ID | B068DB10951 |
NIH Device Record Key | f03552db-59cf-4ed5-a378-12e90bb09d12 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simpex Drill Bit |
Version Model Number | DB-109-5 |
Catalog Number | DB-109-5 |
Company DUNS | 932637023 |
Company Name | SIMPEX MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 800-851-9753 |
info@simpexmedical.com |
Outer Diameter | 2.8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B068DB10951 [Primary] |
HTW | Bit, Drill |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B068DB10951]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-28 |
Device Publish Date | 2019-10-18 |
B068DB25051 | Twist Drill Bit .250" DIA x 5" LG |
B068DB250101 | Twist Drill Bit .250" DIA x 10" LG |
B068DB23651 | Twist Drill Bit .236" DIA x 10" LG |
B068DB235101 | Twist Drill Bit .236" DIA x 10" LG |
B068DB18751 | Twist Drill Bit .187" DIA x 5" LG |
B068DB187101 | Twist Drill Bit .187" DIA x 10" LG |
B068DB17751 | Twist Drill Bit .177" DIA x 5" LG |
B068DB177101 | Twist Drill Bit .177" DIA x 10" LG |
B068DB17151 | Twist Drill Bit .171" DIA x 5" LG |
B068DB171101 | Twist Drill Bit .171" DIA x 10" LG |
B068DB15651 | Twist Drill Bit .156" DIA x 5" LG |
B068DB156101 | Twist Drill Bit .156" DIA x 10" LG |
B068DB14051 | Twist Drill Bit .140" DIA x 5" LG |
B068DB12581 | Twist Drill Bit .125" DIA x 8" LG |
B068DB12551 | Twist Drill Bit .125" DIA x 5" LG |
B068DB12541 | Twist Drill Bit .125" DIA x 4" LG |
B068DB1253251 | Twist Drill Bit .125" DIA x 3.25" LG |
B068DB125101 | Twist Drill Bit .125" DIA x 10" LG |
B068DB10951 | Twist Drill Bit .109" DIA x 5" LG |
B068DB109121 | Twist Drill Bit .109" DIA x 12" LG |
B068DB09851 | Twist Drill Bit .098" DIA x 5" LG |
B068DB09351 | Twist Drill Bit .093" DIA x 5" LG |
B068DB07851 | Twist Drill Bit .078" DIA x 5" LG |
B068DB07051 | Twist Drill Bit .070" DIA x 5" LG |
B068DB06251 | Twist Drill Bit .062" DIA x 5" LG |