Primary Device ID | 09120034306402 |
NIH Device Record Key | 6e5fe8ba-3046-4712-915e-02270c45c2f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sharp Hook |
Version Model Number | KM 47-880 |
Catalog Number | KM 47-880 |
Company DUNS | 303456917 |
Company Name | I.T.S. GmbH |
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 | false |
Lot Batch | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09120034306402 [Primary] |
KIK | Hook, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
[09120034306402]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-10-01 |
Device Publish Date | 2018-11-13 |
09120034304392 - Washer, Flat | 2024-11-11 Washer, Flat, AD=14,0mm, ID=7,0mm |
09120047290026 - Fixation Screw | 2024-11-11 Fixation Screw, PRS upgrade system |
09120047290071 - Bolt | 2024-11-11 Bolt, PRS upgrade system |
09120047297742 - Spike Short | 2024-11-11 Spike Short, PRS upgrade system |
09120047306345 - Fixation Screw | 2024-11-11 Fixation Screw, PRS RXsystem |
09120047306352 - Bolt | 2024-11-11 Bolt, PRS RX System |
09120047306369 - Spike Short | 2024-11-11 Spike Short, PRS RX system |
09120034300196 - Spike | 2024-10-01 Spike, WS 7, PRS Set |