FDA UDI
In Commercial Distribution
🇺🇸 United States
SubQ It! Bioabsorbable Skin Closure System
DI: 00867469000244
·
Model: SU-25
·
OPUS KSD, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SubQ It! Bioabsorbable Skin Closure System
- Primary DI
- 00867469000244
- Version / Model
- SU-25
- Catalog Number
- 422025
- Company Name
- OPUS KSD, INC.
- Labeler DUNS
- 965571289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-31
- Public Version
- 1
- Public Version Date
- 2025-08-08
- Public Version Status
- New
- Public Device Record Key
- 56307f2e-3440-42e0-b661-85e8638193f7
Device Description
SubQ It! Bioabsorbable Driver SU-25 is a single-patient use, skin closure device, preloaded with 25 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
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
- 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
- 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 |
|---|---|---|---|---|
| QQS | Stapler, Skin | General Hospital | 878.4740 | 1 |
| GDW | Staple, Implantable | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34606 | Skin stapler/staple, bioabsorbable | A hand-held manual surgical instrument, preloaded with bioabsorbable skin staples, designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of material(s) that are gradually degraded and absorbed by the body (typically biodegradable polymer). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10867469000241 | GS1 | Shelf Box | 10 | In Commercial Distribution | |
| Primary | 00867469000244 | GS1 |
Customer Contacts
- Phone
- 3399338811
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131563 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- – 49 Degrees Celsius