FDA UDI
In Commercial Distribution
🇺🇸 United States
Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
DI: 00381780000207
·
Model: 3410-ZX
·
Integra Lifesciences Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Primary DI
- 00381780000207
- Version / Model
- 3410-ZX
- Catalog Number
- 3410-ZX
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-11
- Public Version
- 5
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 5bdb799d-5d44-46d7-8378-a1d5ad5cdd69
Device Description
ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK
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
- 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 |
|---|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | 878.4490 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47201 | Collagen haemostatic agent, non-antimicrobial | A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10381780000204 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00381780000207 | GS1 | ||||
| Secondary | M2693410ZX0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P850010 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7.5 cm x 10 cm x 5.0 mm | ||
| Device Size Text, specify | 3 in x 4 in x 5.0 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid excessive heat and humidity