FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemorrhage Occluder Pin
DI: 00861838000309
·
Model: HOP-03
·
TOOLS FOR SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hemorrhage Occluder Pin
- Primary DI
- 00861838000309
- Version / Model
- HOP-03
- Catalog Number
- HOP-03
- Company Name
- TOOLS FOR SURGERY, LLC
- Labeler DUNS
- 841842441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-19
- Public Version
- 2
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 65a15e6f-e3d8-4745-97dc-e7b730c9af40
Device Description
Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery.
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
- 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
- No
- 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 |
|---|---|---|---|---|
| GDW | Staple, Implantable | General, Plastic Surgery | 878.4750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35884 | Skin stapler/staple, non-bioabsorbable | A hand-held manual, surgical instrument preloaded with non-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 metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861838000309 | GS1 |
Customer Contacts
- Phone
- 6314444448
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040109 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Millimeter | |
| Outer Diameter | 10 | Millimeter |