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Scanlan® SURG-I-LOOP® PLUS with blunt needle
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1001-81P
Identity
- Trade Name
- Scanlan® SURG-I-LOOP® PLUS with blunt needle FDA UDI
- Generic Name
- Surgical vessel loop FDA UDI
- Device Name
- SCANLAN® SURG‑I‑LOOP® Plus EUDAMEDScanlan® SURG-I-LOOP® PLUS with blunt needle - Light Green, 37cm long, needle 1mm diam (2/pkg) FDA UDI
- Model / Reference
- 1001-81P EUDAMEDFDA UDI
- Description
- Scanlan® SURG-I-LOOP® PLUS with blunt needle - Light Green, 37cm long, needle 1mm diam (2/pkg) FDA UDI
Identifiers
- Catalog Number
- 1001-81P FDA UDI
- Primary DI / UDI-DI
- 00846159001075 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00846159001075 EUDAMED
- FDA Product Code
- GAE FDA UDI
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical vessel loop FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical vessel loop
Scanlan® SURG-I-LOOP® PLUS with blunt needle by Scanlan International Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical vessel loop.
- Key Surgical Vascular Loops — Key Surgical, LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Devon — Cardinal Health 200, LLC · Class I
- Degania — DEGANIA SILICONE LTD · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc
Sources (2)
- FDA UDI 76bc36ff-1507-4aa0-ae64-aa0e27c86662 35 fields · synced Jul 14, 2026
- EUDAMED e9b892f1-e2d5-4caa-ac0a-e2fb239dd42a 61 fields · synced Jul 14, 2026