Identity
- Trade Name
- remOVE FBR Set FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps | alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap) FDA UDI
- Model / Reference
- 12 FDA UDI
- Description
- The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps | alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap) FDA UDI
Identifiers
- Catalog Number
- 400.05 FDA UDI
- Primary DI / UDI-DI
- 04260206310785 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible endoscopic tissue manipulation forceps, single-use
remOVE FBR Set by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Flexible endoscopic tissue manipulation forceps, single-use.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI ad673a45-404d-428a-9233-0e95e3faa4ff 36 fields · synced Jun 8, 2026