FDA UDI
In Commercial Distribution
🇺🇸 United States
GYNECARE INTERCEED
DI: 10705031147843
·
Model: 4350XL
·
ETHICON, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GYNECARE INTERCEED
- Primary DI
- 10705031147843
- Version / Model
- 4350XL
- Catalog Number
- 4350XL
- Company Name
- ETHICON, LLC
- Labeler DUNS
- 829465157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-20
- Public Version
- 8
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 773a32bb-4234-4dd0-b91c-09ce92cffcfb
Device Description
Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose
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
- MR Safe
- 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 |
|---|---|---|---|---|
| MCN | BARRIER, ABSORABLE, ADHESION | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34212 | Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated | A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705031147840 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10705031147843 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P880047 | 000 |
| P880047 | 020 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 86 Degrees Fahrenheit