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Top Shelf Orthopedics

FDA UDI

Class I (US FDA UDI)

by Top Shelf Manufacturing, LLC

Identity

Trade Name
Top Shelf Orthopedics FDA UDI
Generic Name
Upper-limb traction wrap/trap, single-use FDA UDI
Device Name
Standard Sleeve, Sterile FDA UDI
Model / Reference
530002 FDA UDI
Description
Standard Sleeve, Sterile FDA UDI

Identifiers

Catalog Number
530002 FDA UDI
Primary DI / UDI-DI
00850016589019 FDA UDI
FDA Product Code
KQZ FDA UDI
GMDN Term
Upper-limb traction wrap/trap, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.5890 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Upper-limb traction wrap/trap, single-use

Top Shelf Orthopedics by Top Shelf Manufacturing, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Upper-limb traction wrap/trap, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Top Shelf Manufacturing, LLC

Sources (1)

  • FDA UDI 6adb8a63-7dc9-4c3f-9bd2-0e1d9ca60574 35 fields · synced Jun 9, 2026