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Repex

FDA UDI

Class II (US FDA UDI)

by Hill Laboratories

Identity

Trade Name
REPEX FDA UDI
Generic Name
Body arch traction table FDA UDI
Model / Reference
REPEX FDA UDI

Identifiers

Primary DI / UDI-DI
00860001452518 FDA UDI
510(k) Number
K043239 FDA UDI
K925271 FDA UDI
FDA Product Code
ITH FDA UDI
GMDN Term
Body arch traction table FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5900 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Body arch traction table

Repex by Hill Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body arch traction table.

Cleared under the same submission

K043239 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hill Laboratories

Sources (1)

  • FDA UDI 3cd3464e-fb3c-4f94-87f4-839803351983 33 fields · synced Jun 8, 2026