Identity
- Trade Name
- VascuTape Radiopaque Tape FDA UDI
- Generic Name
- X-ray film ruler FDA UDI
- Device Name
- Glow 'N Tell 55cm Tape (20 Strips) FDA UDI
- Model / Reference
- 1108-20 FDA UDI
- Description
- Glow 'N Tell 55cm Tape (20 Strips) FDA UDI
Identifiers
- Catalog Number
- 1108-20 FDA UDI
- Primary DI / UDI-DI
- 00840663100385 FDA UDI
- 510(k) Number
- K932184 FDA UDI
- FDA Product Code
- KFX FDA UDI
- GMDN Term
- X-ray film ruler FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3500 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
Category: X-ray film ruler
VascuTape Radiopaque Tape by LeMaitre Vascular, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- LeMaitre Vascular, Inc.
Sources (2)
- FDA UDI bb4aabf0-11b5-44aa-8c1e-78c388c171f7 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026