FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040006399
·
Model: 1127158
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040006399
- Version / Model
- 1127158
- Catalog Number
- 1127158
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2018-10-16
- Public Version Status
- Update
- Public Device Record Key
- f6a5f581-af71-4736-824b-ca9e39a1bf3e
Device Description
Topical Skin Adh Flex w/Tips
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
- Yes
- MRI Safety
- MR Conditional
- 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
- Yes
- Sterilization Methods
- Peracetic Acid
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MPN | Tissue adhesive for the topical approximation of skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58779 | Dermal surgical adhesive/sealant applicator | A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040006399 | GS1 | ||||
| Package | 10304040006402 | GS1 | Case | 10 | Not in Commercial Distribution | 2017-10-02 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.5 | Milliliter | |
| Device Size Text, specify | Ampoule 0.5ml, 10/box |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 22 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not exceed 22degreeC