TwistCut™ EndoSorb bioabsorbable Snap-Off Screw FP25028
GUDID 04048266010322
PLGA sterile
Merete GmbH
Bioabsorbable orthopaedic bone screw| Primary Device ID | 04048266010322 |
| NIH Device Record Key | 81c68446-912d-4900-9960-72bedd3a13ef |
| Commercial Distribution Discontinuation | 2020-11-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TwistCut™ EndoSorb bioabsorbable Snap-Off Screw |
| Version Model Number | 2.5 28 |
| Catalog Number | FP25028 |
| Company DUNS | 313267265 |
| Company Name | Merete 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 2.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266010322 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102777
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2015-10-15 |
Devices Manufactured by Merete GmbH
| 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™ | 2024-07-09 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 |
Trademark Results [TwistCut]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TWISTCUT 90350569 not registered Live/Pending |
Guangzhou Innox Tools Co., Ltd. 2020-12-01 |
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