Primary Device ID | 07630055305701 |
NIH Device Record Key | bfa72e41-57dc-4aa9-9076-e97f6099ee3b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Offset reamer handle - Dual coupling |
Version Model Number | 50244500 |
Catalog Number | 10-502-457-04 |
Company DUNS | 485098284 |
Company Name | Incipio Devices SA |
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 | false |
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 |
---|---|
GS1 | 07630055305701 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
[07630055305701]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-08 |
Device Publish Date | 2025-04-30 |
07630055300393 | Offset Reamer Handle - Dual Coupling, Core system sold without power attachment |
07630055304995 | Offset reamer handle core assembly without power coupling |
07630055305701 | Offset Reamer Handle, Dual Coupling connection sold without power coupling |