Primary Device ID | J021303870020 |
NIH Device Record Key | a98e57aa-1106-4ff9-a8f0-71e808b399ac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpeedControl SC1 (M-UK1023) |
Version Model Number | 30387002 |
Company DUNS | 300238441 |
Company Name | W & H Dentalwerk Bürmoos GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J021303870020 [Direct Marking] |
HIBCC | J021303870021 [Primary] |
ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-20 |
Device Publish Date | 2023-10-12 |
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