FDA UDI In Commercial Distribution 🇺🇸 United States

Strauss Surgical

DI: 00851925007267 · Model: STS-ACC-6000-SCOCK · AMERICAN MEDICAL ENDOSCOPY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Strauss Surgical
Primary DI
00851925007267
Version / Model
STS-ACC-6000-SCOCK
Company Name
AMERICAN MEDICAL ENDOSCOPY, INC.
Labeler DUNS
024725124
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-20
Public Version
2
Public Version Date
2023-01-02
Public Version Status
Update
Public Device Record Key
826b9db3-936f-453d-9367-de0f46fe3206

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
MR Safe
Direct Marking Exempt
No
PM Exempt
No
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
FGB Ureteroscope And Accessories, Flexible/Rigid

GMDN Terms

Code Name
60760 Endoscope channel support kit

Identifiers

Type ID
Primary 00851925007267

Premarket Submissions

Submission Number Supplement Number
K992527 000