| Primary Device ID | 04048266054401 |
| NIH Device Record Key | 548d2c29-f71c-421b-a7fd-5f917e1fab9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuoThread™ |
| Version Model Number | CB20062 |
| Company DUNS | 313267265 |
| Company Name | Merete 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 | false |
| 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(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com | |
| Phone | +1(630)869-1092 |
| service@merete-medical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266054401 [Primary] |
| HTW | BIT, DRILL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
[04048266054401]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-09 |
| Device Publish Date | 2024-07-01 |
| 04048266076830 - N/A | 2024-10-28 Countersink for 1/4'' Coupling (for Ø 6,5 mm screws) cannulated for Ø2,0 mm K-Wire, non-sterile |
| 04048266054401 - DuoThread™ | 2024-07-09DuoThread™ Drill bit Ø2.0 mm, Length: 62 mm, canulated, non-sterile |
| 04048266054401 - DuoThread™ | 2024-07-09 DuoThread™ Drill bit Ø2.0 mm, Length: 62 mm, canulated, non-sterile |
| 04048266076823 - N/A | 2024-07-09 Double drill sleeve cannulated for K-wire 2.0 and Drill 5.0 non-sterile |
| 04048266077080 - N/A | 2024-07-09 T-Handle with 1/4'' chuck (for screws Ø 6,5mm) non-sterile |
| 04048266078490 - N/A | 2024-07-09 Small handle coupling for Ao - prug-in part with dia. 17x80 mm - silicone length, knob at the back (demountable), non-sterile |
| 04048266167316 - N/A | 2024-07-09 Universal Length Gauge für K-wire 230 mm non-sterile |
| 04048266183347 - N/A | 2024-07-08 Drill 2.0 140 AO-Connector color-coated white non-sterile, single-use |
| 04048266183354 - N/A | 2024-07-08 Drill 2.5 140 AO-Connector color-coated magenta non-sterile, single-use |