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Grappler™ Suture Anchor System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name
Grappler™ Suture Anchor System FDA UDI
Generic Name
Bone tap, single-use FDA UDI
Device Name
5.5mm cannulated tap, chronic anchor FDA UDI
Model / Reference
P44-960-1055-S FDA UDI
Description
5.5mm cannulated tap, chronic anchor FDA UDI

Identifiers

Catalog Number
P44-960-1055-S FDA UDI
Primary DI / UDI-DI
00889795119025 FDA UDI
FDA Product Code
HWX FDA UDI
GMDN Term
Bone tap, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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
MRI Safety
MR Unsafe FDA UDI

Category: Bone tap, single-use

Grappler™ Suture Anchor System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 2aedccf5-b3f6-4b89-b120-15b882202d44 34 fields · synced Jun 1, 2026