FDA UDI In Commercial Distribution 🇺🇸 United States

Integra®

DI: 10381780174752 · Model: 750600 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Integra®
Primary DI
10381780174752
Version / Model
750600
Catalog Number
750-600
Company Name
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Labeler DUNS
081277700
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-12-29
Public Version
10
Public Version Date
2023-08-15
Public Version Status
Update
Public Device Record Key
eb3d6756-1055-42ca-be62-b11525000118

Device Description

Integra® 1/1 Size Perforated Basket And Feet, 21-1/4"x10"x2-1/4"

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
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
KCT Sterilization wrap containers, trays, cassettes & other accessories

GMDN Terms

Code Name
64239 Sterilizer/disinfector rack instrument-holding insert, reusable

Identifiers

Type ID
Secondary M2747506001
Primary 10381780174752

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K102146 000
K112090 000