FDA UDI In Commercial Distribution 🇺🇸 United States

Orthopedic Fracture Attachment Kit, Berchtold

DI: 00810105030006 · Model: 3-1000-001 · COMPOSITE MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Orthopedic Fracture Attachment Kit, Berchtold
Primary DI
00810105030006
Version / Model
3-1000-001
Catalog Number
OZ 7531775
Company Name
COMPOSITE MANUFACTURING, INC.
Labeler DUNS
947090650
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-14
Public Version
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
0ba62f8e-790e-4bc7-8df8-d13416244818

Device Description

Orthopedic fracture attachment system used to pull traction and articulate the legs of patient for various procedures.

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
No
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
BWN Table And Attachments, Operating-Room

GMDN Terms

Code Name
42308 Operating table orthopaedic extension

Identifiers

Type ID
Primary 00810105030006

Customer Contacts

Phone
9493617580