FDA UDI
In Commercial Distribution
🇺🇸 United States
Womed Leaf
DI: 03770016478052
·
Model: LEAF-L
·
WOMED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Womed Leaf
- Primary DI
- 03770016478052
- Version / Model
- LEAF-L
- Company Name
- WOMED
- Labeler DUNS
- 270778790
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-24
- Public Version
- 2
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- b60542fc-7a33-4500-9d2f-74c43a573520
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 |
|---|---|---|---|---|
| MCN | Barrier, Absorbable, Adhesion | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64416 | Surgical anti-adhesion material, nonimplantable | A material intended to be placed in the body short term (<= 30 days) to prevent the abnormal fibrous union (adhesion) between one body part/tissue to another, or between one body part/tissue and a dressing, following a surgical procedure. It is made of a single or composite polymer (e.g., hydrogel, silicone) in the form of a barrier membrane or fluid dressing, and may be cut to a desired size/shape. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03770016478052 | GS1 | ||||
| Package | 13770016478059 | GS1 | Cardboard box | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240015 | 001 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 8 Degrees Celsius