FDA UDI In Commercial Distribution 🇺🇸 United States

Exact Medical Manufacturing

DI: 06975424194557 · Model: 11718EU · EXACT MEDICAL MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Exact Medical Manufacturing
Primary DI
06975424194557
Version / Model
11718EU
Catalog Number
11718EU
Company Name
EXACT MEDICAL MANUFACTURING, INC.
Labeler DUNS
014464314
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-31
Public Version
1
Public Version Date
2023-11-08
Public Version Status
New
Public Device Record Key
2d66d2b7-b6a3-4da8-ad98-3cb07dbf5e84

Device Description

Micromate Control Unit Drape

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
Yes
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, Surgical

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 16975424194554
Primary 06975424194557
Package 26975424194551