Identity
- Trade Name
- NAMIC FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- ES07638 REV C - TARGET (80519412) PG FDA UDI
- Model / Reference
- 80519412 FDA UDI
- Description
- ES07638 REV C - TARGET (80519412) PG FDA UDI
Identifiers
- Catalog Number
- 80519412 FDA UDI
- Primary DI / UDI-DI
- 20193489067146 FDA UDI
- FDA Product Code
- LIT FDA UDI
- GMDN Term
- Torque manipulation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Torque manipulation device
Namic by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Torque manipulation device.
- Olcott — COOK INCORPORATED · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class II
- VSZL — TELEFLEX INCORPORATED · Class II
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
- K2M General Instruments — K2M, INC. · Class I
- Cook — COOK INCORPORATED · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 79b00658-c1e7-42b7-930a-52826d1652c2 36 fields · synced Jun 8, 2026