FDA UDI In Commercial Distribution 🇺🇸 United States

WHITE BOX

DI: M684HWBO00351 · Model: HWBO0035 · Microport Orthopedics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
WHITE BOX
Primary DI
M684HWBO00351
Version / Model
HWBO0035
Catalog Number
HWBO0035
Company Name
Microport Orthopedics Inc.
Labeler DUNS
079118736
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-22
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
597b9d5b-db07-4201-a38d-06368048b5ea

Device Description

PRIMARY HIP FEM NECK SLEEVE SHORT -3.5MM

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

GMDN Terms

Code Name
59688 Femoral head/stem prosthesis adaptor

Identifiers

Type ID
Direct Marking HWBO0035
Primary M684HWBO00351

Customer Contacts