Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Laparoscopic blunt dissector FDA UDI
- Device Name
- HARMONIC ACE+7 SHEARS 5MM X 36CM FDA UDI
- Model / Reference
- HARH36R FDA UDI
- Description
- HARMONIC ACE+7 SHEARS 5MM X 36CM FDA UDI
Identifiers
- Catalog Number
- HARH36R FDA UDI
- Primary DI / UDI-DI
- 10193489081329 FDA UDI
- 510(k) Number
- K193563 FDA UDI
- FDA Product Code
- NLQ FDA UDI
- GMDN Term
- Laparoscopic blunt dissector FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laparoscopic blunt dissector
Medline by Medline Industries, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic blunt dissector.
- Snowden-Pencer — STERIS CORPORATION · Class II
- Flex — Medrobotics Corporation · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- CORE DYNAMICS — Conmed Corporation · Class II
- FLEX — Medrobotics Corporation · Class II
- CORE DYNAMICS — Conmed Corporation · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
Cleared under the same submission
K193563 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 83819692-ad8b-4ede-9cf3-41615d4afbcd 36 fields · synced Jun 6, 2026