Identity
- Trade Name
- Boston Endo Surgical Technologies LLC FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Bayonet Bipolar Forceps Straight Tip FDA UDI
- Model / Reference
- 1590-11 FDA UDI
- Description
- Bayonet Bipolar Forceps Straight Tip FDA UDI
Identifiers
- Catalog Number
- 1590-11 FDA UDI
- Primary DI / UDI-DI
- 00853508002638 FDA UDI
- 510(k) Number
- K131058 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, 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 — 11.6 Inch FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Boston Endo Surgical Technologies LLC by Lacey Manufacturing Company Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131058 also covers:
- BE-ST Bipolar Forceps — LACEY MANUFACTURING COMPANY LLC
- BE-ST Bipolar Forceps — LACEY MANUFACTURING COMPANY LLC
- BE-ST Bipolar Forceps — LACEY MANUFACTURING COMPANY LLC
- BE-ST Bipolar Forceps — LACEY MANUFACTURING COMPANY LLC
- BE-ST Bipolar Forceps Straight — LACEY MANUFACTURING COMPANY LLC
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC
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
- Lacey Manufacturing Company Llc
Sources (1)
- FDA UDI 140d5d98-6e9e-44ad-8fec-6748d0cbccfb 37 fields · synced May 30, 2026