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Baby Gorilla/Gorilla Plating System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name
Baby Gorilla/Gorilla Plating System FDA UDI
Generic Name
Bone marrow explant needle FDA UDI
Device Name
Bone Marrow Harvest Needle FDA UDI
Model / Reference
P99-997-0411 FDA UDI
Description
Bone Marrow Harvest Needle FDA UDI

Identifiers

Catalog Number
P99-997-0411 FDA UDI
Primary DI / UDI-DI
00889795049087 FDA UDI
FDA Product Code
GAA FDA UDI
GMDN Term
Bone marrow explant needle FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Bone marrow explant needle

Baby Gorilla/Gorilla Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone marrow explant needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 4e321717-7a74-41f2-929c-09acb3aa8121 34 fields · synced May 30, 2026