FDA UDI In Commercial Distribution 🇺🇸 United States

HCS

DI: 00810132040641 · Model: HCS0212 · Concordance Healthcare Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
HCS
Primary DI
00810132040641
Version / Model
HCS0212
Company Name
Concordance Healthcare Solutions LLC
Labeler DUNS
080220245
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-07
Public Version
1
Public Version Date
2023-04-17
Public Version Status
New
Public Device Record Key
9bafa1d8-684d-404a-b2e5-17a604bcca49

Device Description

Lubricating Jelly, 5g Foil Pack, Sterile

Device Characteristics

Single Use
Yes
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KMJ Lubricant, Patient

GMDN Terms

Code Name
60796 General-body orifice lubricant

Identifiers

Type ID
Package 30810132040642
Primary 00810132040641
Package 10810132040648