FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlas SSLR Buttress Assembly
DI: 00851677007140
·
Model: IPN928199
·
STANDARD BARIATRICS, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Atlas SSLR Buttress Assembly
- Primary DI
- 00851677007140
- Version / Model
- IPN928199
- Catalog Number
- SSLR23
- Company Name
- STANDARD BARIATRICS, INC
- Labeler DUNS
- 091278068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-10
- Public Version
- 1
- Public Version Date
- 2024-07-18
- Public Version Status
- New
- Public Device Record Key
- 9d18211b-92aa-4b1d-81e7-a4af5bbf1493
Device Description
Atlas SSLR Buttress Assembly
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47818 | Staple line-reinforcement strip | A sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851677007140 | GS1 | ||||
| Package | 20851677007144 | GS1 | Case | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231603 | 000 |