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Rtmed

FDA UDI

Class II (US FDA UDI)

by Shandong Haidike Medical Products Co., Ltd.

Identity

Trade Name
RTMED FDA UDI
Generic Name
Silk suture FDA UDI
Model / Reference
0 Without Needle 150cm FDA UDI

Identifiers

Primary DI / UDI-DI
06971642801819 FDA UDI
510(k) Number
K232355 FDA UDI
FDA Product Code
GAP FDA UDI
GMDN Term
Silk suture FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Silk suture

Rtmed by Shandong Haidike Medical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silk suture.

Cleared under the same submission

K232355 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shandong Haidike Medical Products Co., Ltd.

Sources (1)

  • FDA UDI 2567849e-b086-40a6-b93d-ce3931526dd8 33 fields · synced May 30, 2026