FDA UDI In Commercial Distribution 🇺🇸 United States

SURGICAL BLADE

DI: 16945630117449 · Model: 10-0170 · Sterilance Medical (Suzhou) Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
SURGICAL BLADE
Primary DI
16945630117449
Version / Model
10-0170
Company Name
Sterilance Medical (Suzhou) Inc.
Labeler DUNS
554434897
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2023-03-21
Public Version
1
Public Version Date
2023-03-29
Public Version Status
New
Public Device Record Key
884d0e70-a8b9-4ec6-9d16-8cd6deaa66a4

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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GES Blade, Scalpel

GMDN Terms

Code Name
37445 Manual scalpel blade, single-use

Identifiers

Type ID
Package 36945630117443
Primary 16945630117449
Unit of Use 06945630117442