FDA UDI
In Commercial Distribution
🇺🇸 United States
ComforTen® Multiple Skin Test System
DI: 00365044000011
·
Model: 80000000021
·
Jubilant Hollisterstier LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- ComforTen® Multiple Skin Test System
- Primary DI
- 00365044000011
- Version / Model
- 80000000021
- Catalog Number
- 80000000021
- Company Name
- Jubilant Hollisterstier LLC
- Labeler DUNS
- 119241112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-11-15
- Public Version
- 1
- Public Version Date
- 2024-11-25
- Public Version Status
- New
- Public Device Record Key
- d0ce37c1-8b4a-44f3-87ae-08109f68b7cb
Device Description
Multiple skin test system with 10 testing legs/tines
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LDH | System, Delivery, Allergen And Vaccine |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45539 | Allergy testing lancet | A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10365044000018 | GS1 | ||||
| Primary | 00365044000011 | GS1 |
Customer Contacts
- Phone
- 800.495.7437
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K953939 | 000 |