Identity
- Trade Name
- MiniLap Percutaneous Surgical System, MiniGrip Babcock Grasper EUDAMEDMINILAP FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- MiniGrip Graspers, various types EUDAMEDBabcock Grasper FDA UDI
- Model / Reference
- PGBK300 EUDAMEDIPN922571 FDA UDI
- Description
- Babcock Grasper FDA UDI
Identifiers
- Catalog Number
- PGBK300 FDA UDI
- Primary DI / UDI-DI
- 14026704738004 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000130K6 EUDAMED
- 510(k) Number
- K113597 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K01020104 MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Ireland 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
Dimensions & Sizes
- Size
- Length — 300 Millimeter FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, single-use
Minilap by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, single-use.
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Cleared under the same submission
K113597 also covers:
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
- Teleflex Incorporated
Sources (2)
- FDA UDI 0fed2aef-4858-4e81-ac58-3c89978cbf3c 37 fields · synced Jul 11, 2026
- EUDAMED b22cfa2b-11d0-4ce2-a445-f4a9e201b363 61 fields · synced Jul 11, 2026