FDA UDI
In Commercial Distribution
🇺🇸 United States
Seprafilm® Single Site
DI: 00358468664112
·
Model: 6641-01
·
GENZYME CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Seprafilm® Single Site
- Primary DI
- 00358468664112
- Version / Model
- 6641-01
- Company Name
- GENZYME CORPORATION
- Labeler DUNS
- 943130096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 7
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- e3c66598-e1a6-4104-9777-0f3024f2c2e9
Device Description
Barrier, Absorbable, Adhesion
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00358468664112 | GS1 | ||||
| Unit of Use | 30358468664113 | GS1 |
Customer Contacts
- Phone
- +1(508)661-1471
- [email protected]
- Phone
- +1(508)271-3304
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 91 | Square centimeter | |
| Device Size Text, specify | one 7 cm x 13 cm membrane/pouch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius