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Juneland

FDA UDI

Class I (US FDA UDI)

by Suzhou Juneland Medical Co., Ltd.

Identity

Trade Name
Juneland FDA UDI
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
implant kit II FDA UDI
Model / Reference
007 FDA UDI
Description
implant kit II FDA UDI

Identifiers

Primary DI / UDI-DI
06976143660071 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, single-use 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/maxillofacial surgical procedure kit, non-medicated, single-use

Juneland by Suzhou Juneland Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suzhou Juneland Medical Co., Ltd.

Sources (1)

  • FDA UDI b633c5f3-1c59-4266-a0e6-04b386447cfa 33 fields · synced May 31, 2026