FDA UDI In Commercial Distribution 🇺🇸 United States

MacImpress

DI: D105VP9007MI2 · Model: VP-9007-MI · Surgimac LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4

Basic Information

Brand Name
MacImpress
Primary DI
D105VP9007MI2
Version / Model
VP-9007-MI
Company Name
Surgimac LLC
Labeler DUNS
060635048
Distribution Status
In Commercial Distribution
Device Count in Pkg
4
Record Status
Published
Publish Date
2025-09-25
Public Version
1
Public Version Date
2025-10-03
Public Version Status
New
Public Device Record Key
d9371321-4b5d-40fb-87ad-877cbcbab175

Device Description

MacImpress VPS Impression Material Heavy Body, Regular Set, 50 ml Cartridges, 4/Pk

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
No
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ELW Material, Impression

GMDN Terms

Code Name
17844 Dental articulation paste/solution

Identifiers

Type ID
Unit of Use D105VP9007MI21
Primary D105VP9007MI2