FDA UDI In Commercial Distribution 🇺🇸 United States

Medline-Microtek

DI: 00748426147410 · Model: Probe Covers · Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Medline-Microtek
Primary DI
00748426147410
Version / Model
Probe Covers
Catalog Number
APC1295
Company Name
Microtek Medical LLC
Labeler DUNS
106908437
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-30
Public Version
1
Public Version Date
2026-02-09
Public Version Status
New
Public Device Record Key
553687c6-4d88-4835-9297-24d01188e6c2

Device Description

Adhesion™ Intraoperative Probe Cover, 10 cm x 244 cm (4 in x 96 in)

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
PUI Drape, Surgical, Exempt

GMDN Terms

Code Name
44714 Intraoperative ultrasound imaging transducer cover

Identifiers

Type ID
Package 10748426147417
Primary 00748426147410
Package 20748426147414

Customer Contacts