FDA UDI In Commercial Distribution 🇺🇸 United States

Biogel Sensor®

DI: 05060097932375 · Model: 82560 · Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Biogel Sensor®
Primary DI
05060097932375
Version / Model
82560
Company Name
Mölnlycke Health Care AB
Labeler DUNS
631770658
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-21
Public Version
3
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
9dd59be3-5df2-417f-9369-2e041e7f8e99

Device Description

Biogel Super Sensitive 6.0x50 US EUR

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
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
KGO Surgeon's gloves

GMDN Terms

Code Name
47178 Hevea-latex surgical glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Package 05060097932535
Package 05060097932450
Primary 05060097932375

Customer Contacts

Phone
+46737733775

Device Sizes

Type Value Unit Text
Device Size Text, specify 6.0