FDA UDI In Commercial Distribution 🇺🇸 United States

TempSpan

DI: 00814978022236 · Model: N69AF · Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TempSpan
Primary DI
00814978022236
Version / Model
N69AF
Company Name
Kerr Corporation
Labeler DUNS
199354556
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-01
Public Version
3
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
50303d07-58dc-4273-9ddc-cd8055f2cc3c

Device Description

Temporary C&B Material; B1

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBG CROWN AND BRIDGE, TEMPORARY, RESIN

GMDN Terms

Code Name
31783 Temporary dental crown/bridge

Identifiers

Type ID
Primary 00814978022236

Customer Contacts

Phone
+18005377123

Device Sizes

Type Value Unit Text
Total Volume 50 Milliliter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius