FDA UDI In Commercial Distribution 🇺🇸 United States

HP300Plus Automatic Tissue Processor

DI: 06971182570947 · Model: HP300Plus · Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HP300Plus Automatic Tissue Processor
Primary DI
06971182570947
Version / Model
HP300Plus
Company Name
Dakewe (Shenzhen) Medical Equipment Co., Ltd.
Labeler DUNS
554456618
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-06
Public Version
2
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
b78977ad-9076-425e-b828-4485eb82af44

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IEO Processor, Tissue, Automated

GMDN Terms

Code Name
57859 Tissue processor IVD, automated/semi-automated

Identifiers

Type ID
Primary 06971182570947