FDA UDI
In Commercial Distribution
🇺🇸 United States
Gelfilm
DI: 00300090297015
·
Model: Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
·
PHARMACIA & UPJOHN COMPANY LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Gelfilm
- Primary DI
- 00300090297015
- Version / Model
- Gelfilm® Sterile Ophthalmic Film Ophthalmic film 6's (12.5 sq cm)
- Company Name
- PHARMACIA & UPJOHN COMPANY LLC
- Labeler DUNS
- 618054084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-22
- Public Version
- 7
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 7ec9b498-7330-4f1f-924b-7cda50e75fd7
Device Description
Anti-adhesion dressing, bioabsorbable
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HQX | IMPLANT, ORBITAL, EXTRA-OCULAR | Ophthalmic | 886.3340 | 2 |
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 | 00300090297039 | GS1 | Carton | 6 | In Commercial Distribution | |
| Primary | 00300090297015 | GS1 |
Customer Contacts
- Phone
- +1(484)865-6166
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 50 | Millimeter | |
| Device Size Text, specify | Thickness of film ranges from 0.060 to 0.175 mm | ||
| Width | 25 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- See USP Controlled Room Temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius