Identity
- Trade Name
- ReNew Cobra Tooth Grasper Tip EUDAMEDReNew FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- ReNew Disposable Tips EUDAMEDCobra Tooth Grasper Tip, Disposable FDA UDI
- Model / Reference
- 3412 EUDAMEDFDA UDI
- Description
- Cobra Tooth Grasper Tip, Disposable FDA UDI
Identifiers
- Catalog Number
- 3412 FDA UDI
- Primary DI / UDI-DI
- 00811099013884 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC004SB EUDAMED
- Unit of Use DI
- 00811099013914 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Rigid endoscopic tissue manipulation forceps, single-use
ReNew by Microline Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Rigid endoscopic tissue manipulation forceps, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microline Surgical, Inc.
Sources (2)
- FDA UDI a1b37b69-9ff6-4549-8e67-60c5b5a19e93 34 fields · synced Jul 8, 2026
- EUDAMED ea0dc836-a05e-471d-875b-9bcb640acdc2 61 fields · synced Jul 8, 2026