FDA UDI In Commercial Distribution 🇺🇸 United States

CAPTURE™

DI: 10381780245995 · Model: MAT-000-02 · Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
CAPTURE™
Primary DI
10381780245995
Version / Model
MAT-000-02
Catalog Number
MAT-000-02
Company Name
Ascension Orthopedics, Inc.
Labeler DUNS
942377524
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-09-05
Public Version
10
Public Version Date
2023-02-23
Public Version Status
Update
Public Device Record Key
f3bfea58-e313-4e6f-84e7-2d6ef2e8dbdf
Distribution End Date
2026-12-31

Device Description

CAPTURE™ High Torque Screw System The Capture 7.0mm mat is placed onto the tray.

Device Characteristics

Single Use
No
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
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
12143 Instrument tray, reusable

Identifiers

Type ID
Secondary M269MAT000021
Primary 10381780245995

Customer Contacts

Device Sizes

Type Value Unit Text
Device Size Text, specify NA