Identity
- Trade Name
- OTOSILK™ Graft Dressing FDA UDI
- Generic Name
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
- Device Name
- Size: 100 x 150 mm; Type: Nylon FDA UDI
- Model / Reference
- OT-4601 FDA UDI
- Description
- Size: 100 x 150 mm; Type: Nylon FDA UDI
Identifiers
- Catalog Number
- OT-4601 FDA UDI
- Primary DI / UDI-DI
- EBESOT46010 FDA UDI
- 510(k) Number
- K964534 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Wound-nonadherent dressing, permeable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 150 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Category: Wound-nonadherent dressing, permeable, non-antimicrobial
OTOSILK™ Graft Dressing by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, permeable, non-antimicrobial.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Oil Emulsion Dressing — DERMARITE INDUSTRIES LLC · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- Mepitel® — Mölnlycke Health Care AB · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Cleared under the same submission
K964534 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI c7b1450c-21e9-4434-ad60-c35ac2cb3a52 38 fields · synced Jun 9, 2026