Identity
- Trade Name
- MINILAP FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
- Device Name
- Tong Grasper FDA UDI
- Model / Reference
- IPN914230 FDA UDI
- Description
- Tong Grasper FDA UDI
Identifiers
- Catalog Number
- PGBC300 FDA UDI
- Primary DI / UDI-DI
- 14026704640093 FDA UDI
- 510(k) Number
- K113597 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 300 Millimeter FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, single-use
Minilap by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid endoscopic tissue manipulation forceps, single-use.
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Cleared under the same submission
K113597 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 8b7fa141-804f-4ed0-9f19-a37434b09ec7 37 fields · synced Jun 8, 2026