FDA UDI
In Commercial Distribution
🇺🇸 United States
Peha-Haft Latex Free 8cm x 4m P1 C140
DI: 04049500749961
·
Model: 9324435 Peha-Haft Latex Free 8cm x 4m P1 C140
·
PAUL HARTMANN AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Peha-Haft Latex Free 8cm x 4m P1 C140
- Primary DI
- 04049500749961
- Version / Model
- 9324435 Peha-Haft Latex Free 8cm x 4m P1 C140
- Company Name
- PAUL HARTMANN AG
- Labeler DUNS
- 315768788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 2
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 4d34c141-4fc7-4b29-8284-a0f7112e23cf
Device Description
Peha-Haft Latex Free 8cm x 4m P1 C140
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58964 | Non-adhesive device retention bandage | A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04052199280189 | GS1 | 140 | In Commercial Distribution | ||
| Primary | 04049500749961 | GS1 |