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FIBERGRAFT BG Morsels

FDA UDI

Class II (US FDA UDI)

by Prosidyan, Inc.

Identity

Trade Name
FIBERGRAFT BG Morsels FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
6cc vial of FIBERGRAFT BG Morsels bioactive bone graft substitute FDA UDI
Model / Reference
77000060 FDA UDI
Description
6cc vial of FIBERGRAFT BG Morsels bioactive bone graft substitute FDA UDI

Identifiers

Catalog Number
77000060 FDA UDI
Primary DI / UDI-DI
00856879006717 FDA UDI
510(k) Number
K151154 FDA UDI
FDA Product Code
MQV FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3045 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

FIBERGRAFT BG Morsels by Prosidyan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K151154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prosidyan, Inc.

Sources (1)

  • FDA UDI 6be0b8f1-cf02-44a0-9217-3150af92f4ec 36 fields · synced Jun 6, 2026