FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046963790950
·
Model: TS1050071FP
·
B BRAUN SURGICAL SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046963790950
- Version / Model
- TS1050071FP
- Catalog Number
- TS1050071FP
- Company Name
- B BRAUN SURGICAL SA
- Labeler DUNS
- 511268005
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-02-28
- Public Version Status
- Update
- Public Device Record Key
- b76c341f-5253-4a25-966d-5bcb61f77be0
- Distribution End Date
- 2022-02-24
Device Description
HISTOACRYL CLEAR SKIN ADHESIVE (FP)
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 |
|---|---|---|---|---|
| MPN | Tissue adhesive for the topical approximation of skin | General, Plastic Surgery | 878.4010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58777 | Surgical internal adhesive/sealant, synthetic polymer | A biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963790950 | GS1 | ||||
| Unit of Use | 04046963790943 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Raw material : n-butyl-2-cyanoacrylate | ||
| Device Size Text, specify | Volume : 0.500 ML |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 22 Degrees Celsius