Primary Device ID | 07613327177367 |
NIH Device Record Key | f888dfed-1160-4bf6-8c1e-27665292f6a1 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 5407-300-100 |
Catalog Number | 5407-300-100 |
Company DUNS | 196548481 |
Company Name | STRYKER CORPORATION |
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 | false |
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 |
Phone | +1(800)253-3210 |
Inst.Stryker.cs@Stryker.com |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327177367 [Primary] |
ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07613327177367]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2020-01-20 |
Device Publish Date | 2016-09-23 |
07613327163278 - NA | 2025-04-28 |
07613327601138 - OptaBlate | 2025-04-25 Curve 10mm Probe Single Kit |
07613327601145 - OptaBlate | 2025-04-25 Curve 20mm Probe Single Kit |
07613327601152 - OptaBlate | 2025-04-25 Curve 15mm Probe Single Kit |
07613327631883 - OptaBlate | 2025-04-25 Straight 10MM Probe Dual Kit |
07613327631890 - OptaBlate | 2025-04-25 Straight 10MM Probe Single Kit |
07613327626391 - ThermaClear | 2025-04-14 |
07613327626407 - ThermaClear | 2025-04-14 |