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Boss Instruments

FDA UDI

Class II (US FDA UDI)

by Boss Instruments, Ltd.

Identity

Trade Name
Boss Instruments FDA UDI
Generic Name
Surgical support tape, bioabsorbable FDA UDI
Device Name
Fenestrated Diss Fcps, 5mm FDA UDI
Model / Reference
35-5167 FDA UDI
Description
Fenestrated Diss Fcps, 5mm FDA UDI

Identifiers

Catalog Number
35-5167 FDA UDI
Primary DI / UDI-DI
00888515041318 FDA UDI
510(k) Number
K040855 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Surgical support tape, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Boss Instruments by Boss Instruments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040855 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boss Instruments, Ltd.

Sources (1)

  • FDA UDI 9109255f-7306-48ad-9454-643859fdb3e1 37 fields · synced Jun 9, 2026