FDA UDI In Commercial Distribution 🇺🇸 United States

Pin Adaptor

DI: 09421028117883 · Model: ME-PA1000 · ENZTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Pin Adaptor
Primary DI
09421028117883
Version / Model
ME-PA1000
Catalog Number
ME-PA1000
Company Name
ENZTEC LIMITED
Labeler DUNS
592616445
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-17
Public Version
2
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
4479cf8e-c2b2-404f-a030-276d3266d4c5

Device Description

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary 09421028117883