FDA UDI In Commercial Distribution 🇺🇸 United States

Innomed, Inc.

DI: 00840277114488 · Model: 8033-01 · INNOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Innomed, Inc.
Primary DI
00840277114488
Version / Model
8033-01
Catalog Number
8033-01
Company Name
INNOMED, INC.
Labeler DUNS
878427491
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-05
Public Version
1
Public Version Date
2021-10-13
Public Version Status
New
Public Device Record Key
560f59f4-4eac-4b52-9c1e-09590d589342

Device Description

Debris Shield with Reamer Slot

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
No
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
34004 Surgical instrument guard, reusable

Identifiers

Type ID
Primary 00840277114488