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Otological Silicone Strips

FDA UDI

Class I (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Otological Silicone Strips FDA UDI
Generic Name
Scar management dressing, single-use, sterile FDA UDI
Device Name
Size: 0.12 x 45 x 6 mm; Color: Blue FDA UDI
Model / Reference
SS-4506B FDA UDI
Description
Size: 0.12 x 45 x 6 mm; Color: Blue FDA UDI

Identifiers

Catalog Number
SS-4506B FDA UDI
Primary DI / UDI-DI
EBESSS4506B0 FDA UDI
FDA Product Code
MDA FDA UDI
GMDN Term
Scar management dressing, single-use, sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4025 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

Yes

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Depth — 0.12 Millimeter FDA UDI
Width — 6 Millimeter FDA UDI
Length — 45 Millimeter FDA UDI

Category: Scar management dressing, single-use, sterile

Otological Silicone Strips by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scar management dressing, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI 49ee7c5f-0d31-4417-8e0e-95a30d2f8141 37 fields · synced Jun 9, 2026