FDA UDI
In Commercial Distribution
🇺🇸 United States
Strauss Surgical
DI: 00850024135697
·
Model: STS-ART-40-0003
·
AMERICAN MEDICAL ENDOSCOPY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Strauss Surgical
- Primary DI
- 00850024135697
- Version / Model
- STS-ART-40-0003
- Company Name
- AMERICAN MEDICAL ENDOSCOPY, INC.
- Labeler DUNS
- 024725124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-02
- Public Version
- 5
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- e4f3f92b-b885-4921-8460-ae0fe2f5cdb4
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBH | Accessories, Arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35948 | Endoscopic surgical probe | A slender, rod-like, hand-held manual surgical instrument intended to be inserted through an endoscope (e.g., arthroscope, laparoscope) to explore, measure, and/or perform therapeutic procedures during various types of surgical interventions (excludes cryosurgery). It is made of metallic and/or synthetic polymer material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850024135697 | GS1 |