FDA UDI In Commercial Distribution 🇺🇸 United States

Coulmed

DI: 10810087352575 · Model: AC03-P · Coulmed Products Group LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Coulmed
Primary DI
10810087352575
Version / Model
AC03-P
Catalog Number
AC03-P
Company Name
Coulmed Products Group LLC
Labeler DUNS
047115479
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-06
Public Version
1
Public Version Date
2023-01-16
Public Version Status
New
Public Device Record Key
bc150a42-50cb-4362-b7ba-9732686d5dec

Device Description

Replacement 2" Thick Radiolucent Pad for Free-Access Style Hand & Arm Surgery Table, Standard Foam with Black Conductive Covering.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CCX SUPPORT, PATIENT POSITION

GMDN Terms

Code Name
37047 Arm procedure positioner, reusable

Identifiers

Type ID
Primary 10810087352575