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PragmaTool

FDA UDI

Class I (US FDA UDI)

by Hangzhou Rejoin Mastin Medical Device Co., Ltd.

Identity

Trade Name
PragmaTool FDA UDI
Generic Name
Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Retrograde Reamer, Tibia, 8.0mm, S FDA UDI
Model / Reference
801961700 FDA UDI
Description
Retrograde Reamer, Tibia, 8.0mm, S FDA UDI

Identifiers

Primary DI / UDI-DI
06972884983042 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Arthroscopic surgical procedure kit, non-medicated, reusable 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Arthroscopic surgical procedure kit, non-medicated, reusable

PragmaTool by Hangzhou Rejoin Mastin Medical Device Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hangzhou Rejoin Mastin Medical Device Co., Ltd.

Sources (1)

  • FDA UDI 6c6d61de-b5b4-46be-a2fd-72322e858e32 33 fields · synced May 29, 2026