FDA UDI
In Commercial Distribution
🇺🇸 United States
GELFOAM-JMI™ Sponge Kit
DI: 00360793310107
·
Model: Size 100
·
PHARMACIA & UPJOHN COMPANY LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GELFOAM-JMI™ Sponge Kit
- Primary DI
- 00360793310107
- Version / Model
- Size 100
- Company Name
- PHARMACIA & UPJOHN COMPANY LLC
- Labeler DUNS
- 618054084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-05
- Public Version
- 7
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 82696ab3-3151-43b2-b0b1-c2515bd2bb9a
Device Description
Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Sponge USP and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 44057 | General surgical procedure kit, medicated | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00360793310107 | GS1 |
Customer Contacts
- Phone
- +1(484)865-6166
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| N18286 | 017 |
| N18286 | 018 |
| N18286 | 020 |
| N18286 | 021 |
| N18286 | 023 |
| N18286 | 024 |
| N18286 | 025 |
| N18286 | 026 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius