FDA UDI In Commercial Distribution 🇺🇸 United States

DEXcam4™ Intra-oral Camera Sheaths

DI: 10618125155870 · Model: 21025 · TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
DEXcam4™ Intra-oral Camera Sheaths
Primary DI
10618125155870
Version / Model
21025
Catalog Number
1.011.4989
Company Name
TIDI PRODUCTS, LLC
Labeler DUNS
063519193
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2023-04-13
Public Version
1
Public Version Date
2023-04-21
Public Version Status
New
Public Device Record Key
cd8eaa99-f7eb-4563-9ec4-4e08eb0792b8

Device Description

Custom fit for: DEXcam4 and DEXcam4HD Re-Order DEXIS Part Number 1.011.4989

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No

Product Codes

Code Name
KQM Camera, Surgical And Accessories

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 20618125155877
Primary 10618125155870
Unit of Use 00618125155873